The total number of transactions in which brand-name drug companies pay to delay the entry of generic competitors continues to decline, and only 5 of 170 final 2015 settlements included generic compensation and entry restriction generic, the Federal Trade Commission (FTC) said in a report released on Wednesday.
Fiscal 2015 is the second full year of filings since the Supreme Court ruled FTC v. Canada. Actavis, Inc. in June 2013, when it concluded that a drug company's transfer to a generic competitor to settle a patent dispute could violate antitrust laws. The decline in fiscal 2015 follows a similar decline revealed in a report from the FTC last year.
"In accordance with the 2014 fiscal year, the number of settlements that can lead to late payment continues to decline significantly as a result of the Actavis decision, even though the total number of settlements filed with the FTC has increased," the report says.
During the 2015 financial year, the total number of definitive settlements was 170, compared to 140 in 2012, 145 in 2013 and 160 in 2014. However, the number of potential deferred payment agreements fell to 14 in 2015, from a high of 40 late payment settlements for fiscal year 2012.
Of these 14, 10 included compensation in the form of a cash payment only for litigation costs (one of which included a cash payment of more than $ 7 million), while the other four included a promise of non-commercialization. an authorized generic in competition with the generic manufacturer for a period.
Ten additional definitive regulations are classified by the FTC as containing "possible compensation" because it is not clear whether certain provisions in the agreements are equivalent to what should be considered compensation for the generic patent applicant.
"For example, an agreement containing a declining royalty structure, in which the generic's obligation to pay royalties is reduced or eliminated if a brand launches an authorized generic product, can have the same effect as an explicit commitment without MGAs. ", says the report. .
In addition, 126 of the 170 final regulations limited the ability of the generic manufacturer to market its product, but did not include explicit or possible compensation ...
Thursday, November 2, 2017
Tuesday, October 24, 2017
UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments
According to a report published Monday, trade associations, manufacturers, universities and researchers gave their opinion on the draft strategy of the UK Medicines and Health Products Regulatory Agency (MHRA) for standards development. pharmacological.
In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.
context
In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."
MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.
These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.
Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.
Consultation Comments
MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."
For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.
For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "
The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.
A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.
Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."
Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.
In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.
context
In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."
MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.
These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.
Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.
Consultation Comments
MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."
For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.
For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "
The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.
A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.
Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."
Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.
Tuesday, October 10, 2017
EMA Adds New Excipients to Labeling Requirements
The European Medicines Agency (EMA) updated on Monday its annex to the European Commission guidelines on the labeling of excipients, adding five new excipients and extending the safety warnings required for 10 others.
Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.
This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.
The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.
The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.
Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.
The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years
Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.
This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.
The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.
The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.
Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.
The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years
Sunday, October 1, 2017
ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation
The International Council of Harmonization (CIE) is considering two new issues, according to the report published Thursday at the group's Montreal meeting in May and June.
Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).
The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.
During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.
Progress in other guidelines
The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.
For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.
The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.
ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.
Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.
The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.
During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.
Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).
The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.
During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.
Progress in other guidelines
The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.
For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.
The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.
ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.
Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.
The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.
During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.
Sunday, September 10, 2017
Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds
In their 15-year data analysis, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Regulatory, Therapeutic and Legal (PORTAL) Program at Brigham and Women's Hospital and Harvard Medical School found that the fastest drug approvals had a higher percentage of tag changes related to safety than those approved for non-accelerated routes.
"More research is needed to understand the underlying factors of the process that contribute to the differential rates in the safety changes that were observed in this analysis," the authors added. "Policymakers are likely to need to ensure that these channels are not overused, that there is sufficient oversight of post-approval compliance approved by these channels, and that patients and clinicians are fully exposed to the risks associated with the widespread use of accelerated development and channels of regulatory review in the approval of new drugs. "
With the implementation of 21st Century Curative legislation, more treatments are expected to receive rapid approvals, especially regenerative medications.
The authors point out that increasing safety tag changes underscore the importance of accelerated follow-up of approved drugs "to help identify emerging problems that require a change in the safety tag as soon as possible," write the authors.
And while drugs that accelerate approval usually include a statement about "clinical benefit ... not established" because of "dependence on an incomplete validated measure," the authors suggest that there must also be formal requirements for manufacturers warn patients about the higher rate of subsequent changes in the safety labeling of drugs approved by channels of accelerated adoption, fast path or priority.
The authors also point out several limitations to their research, including that the rate of safety changes "does not provide a qualitative assessment of the clinical relevance of a particular change.
"For example, adding the" risk of serious cardiovascular events "to the boxed warning of a label in which already had cardiovascular outcomes mentioned could have less clinical impact than the addition of new psychiatric secondary effects that were not included in this section the label, "they write. "Such a qualitative analysis of label changes is complicated by the fact that in some cases the FDA only indicates that a change has been made, but it presents the whole section of the label and in others it emphasizes or italicizes the text but does not indicates what has been changed The FDA's clarity about the exact nature of each label change and the number of changes each month would be helpful in resolving these issues.
Thursday, August 31, 2017
IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018
The International Forum of Pharmaceutical Regulators (IPRF) and the International Program for the Regulation of Generic Drugs (IGDRP) have agreed to consolidate their work in a joint initiative to be operational in January 2018.
According to a summary of the 5th IGDRP meeting in Ottawa in June, the IPRF Management Committee and the IGPRR Steering Committee expressed their support for consolidating the IPRF and IGPRR initiatives to better address the issues Complex and challenges faced by regulatory authorities and organizations.
The consolidation of these two regulatory collaborations should allow for a shared vision for information exchange and regulatory cooperation, maximize synergies and avoid duplication efforts, create a regulatory center for pharmaceutical products that covers all Allowing for closer links with initiatives to simplify the many forms of international regulatory collaboration and improve governance for management committees and technical working groups.
The Consolidated Management Committee intends to hold its first face-to-face meeting in June 2018.
"Given the imminent consolidation of the IPRF with IGDRP, a revised joint strategic vision will be developed for the consolidated entity in the near future," said IPRF.
In addition, the International Council for Harmonization (ICH) Assembly approved a proposal by the IPRF Management Committee that the ICH Secretariat provide support services to the IPRF as of 1 January 2018.
"The Secretariat's support services will cover the needs of the future consolidated entity IPRF and IGDRP," the group added.
The next meeting of the IPRF Management Committee will be held on 12 and 13 November 2017 in Geneva, Switzerland.
According to a summary of the 5th IGDRP meeting in Ottawa in June, the IPRF Management Committee and the IGPRR Steering Committee expressed their support for consolidating the IPRF and IGPRR initiatives to better address the issues Complex and challenges faced by regulatory authorities and organizations.
The consolidation of these two regulatory collaborations should allow for a shared vision for information exchange and regulatory cooperation, maximize synergies and avoid duplication efforts, create a regulatory center for pharmaceutical products that covers all Allowing for closer links with initiatives to simplify the many forms of international regulatory collaboration and improve governance for management committees and technical working groups.
The Consolidated Management Committee intends to hold its first face-to-face meeting in June 2018.
"Given the imminent consolidation of the IPRF with IGDRP, a revised joint strategic vision will be developed for the consolidated entity in the near future," said IPRF.
In addition, the International Council for Harmonization (ICH) Assembly approved a proposal by the IPRF Management Committee that the ICH Secretariat provide support services to the IPRF as of 1 January 2018.
"The Secretariat's support services will cover the needs of the future consolidated entity IPRF and IGDRP," the group added.
The next meeting of the IPRF Management Committee will be held on 12 and 13 November 2017 in Geneva, Switzerland.
Tuesday, July 18, 2017
Regulatory Recon: FDA Accepts Spark's Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate Evenity (17 July 2017)
On the cover: USA
In Focus: International
Pharmaceuticals & Biotechnology
Pharmaceuticals and Biotechnology: Study Results, Filings and Designations
Medical Devices
US: Assorted & Government
Upcoming Meetings & Events
Europe
General Health & Other Interesting Articles
Regulatory recognition is our daily press conference on intelligence to regulatory space, bringing the best new regulations around the world. Every Monday through Friday, we want to get you the latest moments in the approval of new developments, meetings, legal and policy, regulations and guidelines, as well as the latest trends that can influence regulatory professionals and the industry in which they work.
- FDA accepts the gene spark BLA therapy (endpoints) (press)
- Big pharma buys in crowdsourcing for drug discovery (by cable)
- Large pharmaceutical companies spent on share repurchase, but R & D? Not so much (New York Times)
- Pascal Soriot remains AstraZeneca (Financial Times) (final points)
- FDA rejects Amgen romo anti-osteoporosis drug as rival Radius surprises with new CEO (Fierce) (PharmaTimes) (Presse)
- The FDA is firmly committed to the partial coverage of Repros Therapeutics struggling with a large trial application (endpoints)
- CAR T cells "very exciting" as "living medicine" (Medscape)
- The new NIH report found a low morale, persistent concerns about patient safety (Washington Post)
- Gilead rich in species should consider taking Incyte, but it will not be cheap (fierce)
- In truth, Robot will raise 20 million sterile mosquitoes to free California (MIT Technology Review)
- McCain surgery delays vote on health care; The recovery may be more serious than previously thought, according to experts (New York Times)
- US health insurance companies want the proposal to be dropped Senate cross-law (Reuters)
In Focus: International
- This secret clan wants to beat the world's biggest drug makers (Bloomberg)
- The participation of the increases of the meeting of the regulatory committee of EMA non member of the EU ($ type of leaf pink)
- Shire boss said stock price is at odds with the range of drugs (Financial Times)
- TGA Approves Roche Ocrevus for Progressive Primary Recurrent MS (Press)
- The government has earmarked more than £ 120 million for Global Health Research (UK DOH)
- Indian pharmaceutical companies should increase investment in R & D (Economic Times)
- Despite pressure on prices, India's pharmaceutical exports to the US Could increase during the year 18 (Business Standard)
- The implementation program of the clinical inspection program of clinical trials of Chinese regulations (Emergo)
- Does WHO's revised standards mask safety signals in vaccines? ($ -pink sheet)
- Quebec expects $ 1.2 billion savings with new drug market (Bloomberg)
- Brexit talking about the second round: what are the key issues? (Bloomberg)
- The pharmacist must know the unitary European patent in the light of Brexit (Pharmafile)
- Street vendors Port-au-Prince pills (NPR)
Pharmaceuticals & Biotechnology
- FDA Classification on Opioid Prescription Education (MedPage)
- I had the wrong medication. And a $ 2 help band. (New York Times)
- With cancer screening, better safe than sorry? (New York Times)
- This is not the first American opiate additive crisis (Bloomberg)
- Can the FDA climate to be too good? ($ -pink sheet)
- The FDA determined that deuter compounds are different NCE orphan drugs compared to non-deuterated versions (FDA Blog Law)
- Back to the roots of Ipsen (BioCentury)
- For Alsonex target the complement system C5a for the treatment of ALS (BioCentury)
- CAR-T therapy: non-compliance with publication specifications can not prohibit patient use (pink leaves $)
- As part of the taxpayer-funded research, Sanofi's boss says he has never rejected a fair price request for Zika (fierce)
- Novartis says Cosentyx is safe and effective for five years (PharmaTimes)
- Five questions to ... Austin Biotech businessman Laura Bosworth (Xconomy)
- TherapeuticsMD presents the CRL data with FDA (Seeking Alpha) (Presse)
- More fake Avastin found, this time in Cyprus (Fixing Industry)
Pharmaceuticals and Biotechnology: Study Results, Filings and Designations
- CymaBay stocks get a rebound on positive data PBC PHII (end points)
- The Non-Alcoholic Fatty Liver Test / EHNA Phase II Can-Fite with Namodenoson to Begin Recruiting Patients Following the Conclusion of a Successful Clinical Researcher Meeting (Press)
- Onda Life Sciences is launching Phase 1b / 2a clinical trials: PRECISION-HD1 and HD2-precision in patients with Huntington's disease (Press)
- Alzheon presents new data for the leading candidate ALZ-801 in the new Ministry of Agriculture and long-term clinical efficacy at the International Conference of the Alzheimer's Association (Press)
- Merck announces presentations of clinical data and the real world at the International Conference of the Alzheimer's Association (Press)
- Symbiomix Therapeutics announces the publication of key data for the Solosec research for the treatment of bacterial vaginosis (Press)
- Perrigo announces final approval of the FDA for its generic version evaluated by the first envelope of AndroGel®, 1.62% packages (press)
- Impax Announces FDA Approval of Its Generic Tablet (Methylphenidate Tablet) Reviewed by AB Generic CII Rating (Press)
Medical Devices
- Sailing HIV Melanoma Assays to Ensure Regulator Supply (GenomeWeb)
- Mobius Bionics sells the first use of the prosthesis bionic arm LUKE DEKA (MassDevice)
- Study: cybersecurity attacks create a risk of manipulation of medical data, devices (MassDevice)
- Five-year data show that InterStim Therapy (TM) offers efficacy and quality of life improvements for long-term sustainable bladder hypertensive patients (Press)
US: Assorted & Government
- Biosimilars In Medicare payments: CMS Signals will change ($ type of pink sheet)
- The hymn meets Insys a "creative" scheme to gain the return of its analgesic properties (STAT)
- Governors of both parties denounced the Senate bill repeal proposed Obamacare (New York Times)
- The latest Senate health plan cuts costs for chronic diseases (KHN)
- The marginalized health care lobby hinders the Republican health effort (Reuters)
- Sometimes it is forgotten in the express warranty (Law of medicines and devices)
- Calif. Nerve strikes When choosing cardiac surgeons with the highest patient death rates (KHN)
Upcoming Meetings & Events
- FDA Advisory Committee Calendar
Europe
- Gerresheimer allows the safety solution of the West syringe (Reuters)
- The best 'Brexit-tested' tips to tackle the most difficult of EU production (Forbes)
- Pierre Fabre guarantees the Italian distribution rights for Aprotecol de Noventure (Pharmafile)
- India
- Site of the first test laboratory devices in India in Gujarat approved by the Ministry of Health (Pharmabiz)
- Alembic Pharma Opens Rs 300 Million Rupees Unit in Cancer of Gujarat (Economic Times)
- Alkem Laboratories Plant Eliminates FDA Inspection (Economic Times)
- The pharmaceutical industry South has great potential in the production of medicines against chronic disease: S V Veeramani (Pharmabiz)
- Pharmaceutical sector is a major beneficiary of GST because cold chain materials become problems Dr Piyush Gupta (Pharmabiz)
General Health & Other Interesting Articles
- 3-D-Printed Artificial Heart Beats as the real thing, but still not widely used (MIT Technology Review)
Regulatory recognition is our daily press conference on intelligence to regulatory space, bringing the best new regulations around the world. Every Monday through Friday, we want to get you the latest moments in the approval of new developments, meetings, legal and policy, regulations and guidelines, as well as the latest trends that can influence regulatory professionals and the industry in which they work.
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