The United States Food and Drug Administration (FDA) finalized on Friday its version of the Questions and Answers of the International Council on Harmonization (ICH) in addition to the ICH Guidelines for the Development and Manufacture of Substances of Drugs.
The FDA consulted the draft of the question and answer document in February 2017 and, after consultation and other similar consultations of other Members of the ICH Regulations, the ICP Assembly approved the document in August 2017.
Specifically, the Q & A Guide aims to develop the 2012 ICH guide on drug manufacturing, substance development and drug manufacturing (chemical entities and biotechnological / biological entities).
According to the FDA, the question and answer document provides "additional clarifications and favors the convergence on considerations for the selection and justification of the starting materials" for the manufacture of medicines, with a focus on the synthesis of chemical drugs.
The guide, which is the same as the version approved by ICH in August, includes answers to 16 questions on the justification and selection of starting materials, as well as two decision trees focused on the evaluation of a proposed starting substance. an impact on the profile of impurities of the drug substance.
Monday, February 26, 2018
Sunday, February 18, 2018
Imfinzi Approved to Reduce Risk of NSCLC Progression
AstraZeneca Immunotherapy Imfinzi (durvalumab) is now approved to reduce the risk of progression of non-small cell lung cancer (NSCLC) in patients with stage III disease whose tumor can not be removed surgically after chemotherapy treatment and radiation therapy that stops cancer with spread."This is the first approved treatment for NSCLC in Phase III, to reduce the risk of cancer progression, when the cancer has not worsened after chemoradiotherapy," said Richard Pazdur, director of knowledge in oncology at the FDA.
According to Pazdur, while some patients will be cured of the disease after chemotherapy and radiation therapy, the cancer will eventually increase for most patients.
The FDA granted in May 2017 for the first time accelerated Imfinzi approval to treat certain patients with locally advanced or metastatic bladder cancer. The FDA also states that both the priority review that the breakthrough has granted the additional license of biological products (sBLA) AstraZeneca for the new indication.
The FDA said it based the decision to expand the Imfinzi-based label on a randomized study of 713 patients measured progression-free survival (PFS) in patients who had Imfinzi and patients using placebo. In the study, the median PFS for patients using Imfinzi was three times longer than for patients receiving placebo, 16.8 months versus 5.6 months.
With the expanded label, the FDA states that AstraZeneca has accepted a post-marketing commitment (PMC) to provide the organization with the overall survival data of patients who participated in the study.
Sunday, February 11, 2018
Regulatory Reform: Companies and Industry Groups Offer up a Wish List of CDER, CDRH Changes
Johnson & Johnson (J & J) and Abbott, as well as the PhRMA, BIO and AdvaMed industry group presented their priorities for the US Food and Drug Administration's (FDA) call to amend, repeal or replace regulations , according to comments Thursday on the register.
J & J have compiled a list of seven priorities that have been tabled for both CDER and CDRH, including reforms to simplify the way in which information from manufacturers who are not on a product label are disclosed; approval allow for changes to a label without FDA clearance, reducing conflicts of interest for FDA advisory committees (which PhRMA had also requested) and increasing the use of electronic labeling rather than paper.
J & J is also reviewing the FDA's decision to pause a voluntary quality data reporting program via an FDA portal after the industry has called on the agency to take the break.
"We are in agreement with the FDA that manufacturers of quality data to collect and analyze, but collects each company and analyze the data in its own way and adhering to a one-size-fits-all approach requires changes in heavy process. Cosmetic Act authorizes the FDA to require companies to collect data and submit the prescribed formats. We are compliant with the current pause in the additional input program from stakeholders and suggest that manufacturers should not enter to present data quality and statistics these data must be available for review during inspections, "says the comment.
PhRMA also called for changes in the FDA's guidelines on human factors research in the comments of the CDRH, while BIO called for regulatory changes for genetically modified animals.
Mutual approvals and inspections
J & J also suggests that mutual FDA approval of medical devices with the EU allows a medical device "class III ... save lives of vanguard additional data would be postmarketing place to access the patient's treatment options While the commitment is maintained The FDA requirements for Subparts B and C of 21 CFR 814 must be revised to reflect this approach. "
Abbott is appealing to the FDA to withdraw a proposed rule on the electronic submission of labels for certain home appliances that, in its opinion, is "superfluous because the labeling of devices is necessary to accompany medical devices used in distribution commercial. widely available to users and many home appliance manufacturers provide product labeling information on their websites. "
The AdvaMed group of Device Industry made 19 recommendations, covering everything from revisions to the use of symbols in the labeling rule, asking the FDA to consider a paper assessment rather than a prior on-site approval. .
"The increased use of evaluation by the production section of an LDC would save time. Approval inspections are intensive in terms of time and resources, "said the group, suggesting that a change could save $ 10 million.
J & J have compiled a list of seven priorities that have been tabled for both CDER and CDRH, including reforms to simplify the way in which information from manufacturers who are not on a product label are disclosed; approval allow for changes to a label without FDA clearance, reducing conflicts of interest for FDA advisory committees (which PhRMA had also requested) and increasing the use of electronic labeling rather than paper.
J & J is also reviewing the FDA's decision to pause a voluntary quality data reporting program via an FDA portal after the industry has called on the agency to take the break.
"We are in agreement with the FDA that manufacturers of quality data to collect and analyze, but collects each company and analyze the data in its own way and adhering to a one-size-fits-all approach requires changes in heavy process. Cosmetic Act authorizes the FDA to require companies to collect data and submit the prescribed formats. We are compliant with the current pause in the additional input program from stakeholders and suggest that manufacturers should not enter to present data quality and statistics these data must be available for review during inspections, "says the comment.
PhRMA also called for changes in the FDA's guidelines on human factors research in the comments of the CDRH, while BIO called for regulatory changes for genetically modified animals.
Mutual approvals and inspections
J & J also suggests that mutual FDA approval of medical devices with the EU allows a medical device "class III ... save lives of vanguard additional data would be postmarketing place to access the patient's treatment options While the commitment is maintained The FDA requirements for Subparts B and C of 21 CFR 814 must be revised to reflect this approach. "
Abbott is appealing to the FDA to withdraw a proposed rule on the electronic submission of labels for certain home appliances that, in its opinion, is "superfluous because the labeling of devices is necessary to accompany medical devices used in distribution commercial. widely available to users and many home appliance manufacturers provide product labeling information on their websites. "
The AdvaMed group of Device Industry made 19 recommendations, covering everything from revisions to the use of symbols in the labeling rule, asking the FDA to consider a paper assessment rather than a prior on-site approval. .
"The increased use of evaluation by the production section of an LDC would save time. Approval inspections are intensive in terms of time and resources, "said the group, suggesting that a change could save $ 10 million.
Monday, February 5, 2018
Falsified Medicines: EC Report Finds Inconsistent Penalties Throughout the EU
A recent European Commission (EC) report shows that although all EU Member States have implemented laws in accordance with the Falsified Medicines Directive, sanctions for violating these laws vary considerably from one country to another. country to another.
"Sanctions are only effective if they are properly implemented and I urge all EU countries to ensure that criminals who falsify drugs are punished," said Vytenis Andriukaitis, European Commissioner for Health and food security. ensure that criminals catch counterfeit drugs are punished.
According to the report, the maximum imprisonment penalty for falsifying a drug of only one year varies between Sweden, Finland and Greece at age 15 in Austria, Slovenia and Slovakia.
The maximum penalties for the counterfeiting of a medicine range from € 4,300 in Lithuania to € 1 million in Spain. In the United Kingdom, there is no maximum for such fines.
Similarly, maximum prison sentences and misconduct penalties for active substances and excipients vary considerably from one Member State to another.
In addition, the specification differs from what has been criminalized from one Member State to another. For example, Latvia sanctions drug falsification resulting in bodily injury or death, while most Member States criminalize falsification "without the need to prove that the product is dangerous to health" .
The report also notes that it is "difficult to measure the effectiveness of specific national sanctions because of a lack of comprehensive data on incidents in the Member States".
However, experts consulted before the report told the EC that the sanctions "had at least one effect on reducing the presence of counterfeit drugs in the legal distribution chain," but described the administrative sanctions as the most effective deterrent.
But with regard to the sale of illegal drugs, the experts found that criminal sanctions were a more effective deterrent.
As such, the report recommends that Member States introduce additional administrative and criminal penalties for falsified medicines and request countries to reserve sufficient resources to maintain these sanctions.
"Sanctions are only effective if they are properly implemented and I urge all EU countries to ensure that criminals who falsify drugs are punished," said Vytenis Andriukaitis, European Commissioner for Health and food security. ensure that criminals catch counterfeit drugs are punished.
According to the report, the maximum imprisonment penalty for falsifying a drug of only one year varies between Sweden, Finland and Greece at age 15 in Austria, Slovenia and Slovakia.
The maximum penalties for the counterfeiting of a medicine range from € 4,300 in Lithuania to € 1 million in Spain. In the United Kingdom, there is no maximum for such fines.
Similarly, maximum prison sentences and misconduct penalties for active substances and excipients vary considerably from one Member State to another.
In addition, the specification differs from what has been criminalized from one Member State to another. For example, Latvia sanctions drug falsification resulting in bodily injury or death, while most Member States criminalize falsification "without the need to prove that the product is dangerous to health" .
The report also notes that it is "difficult to measure the effectiveness of specific national sanctions because of a lack of comprehensive data on incidents in the Member States".
However, experts consulted before the report told the EC that the sanctions "had at least one effect on reducing the presence of counterfeit drugs in the legal distribution chain," but described the administrative sanctions as the most effective deterrent.
But with regard to the sale of illegal drugs, the experts found that criminal sanctions were a more effective deterrent.
As such, the report recommends that Member States introduce additional administrative and criminal penalties for falsified medicines and request countries to reserve sufficient resources to maintain these sanctions.
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