FDA Approves First PFO Occluder From St. Jude

The Food and Drug Administration (FDA) approved on Friday, Minnesota-based St. Jude Medical Amplatzer PFO occluder, qui est intended to reduce the risk of stroke in some patients who previously had a stroke.

The device - qui was sold more than a decade under a Humanitarian Device Exemption (HDE) target ago was voluntarily withdrawn by St. Jude in 2006 after the FDA concluded that her goal was greater than 4,000 patients population - is specifically for Tal patients who previously had a stroke that is believed to be caused by a blood clot passing through a small hole in the heart, expired called patent foramen ovale (PFO), and then traveled to the brain.

Since 2006 (when the device was withdrawn from the market), this is the first occluder heart FDA approved It is especially indicated to close the PFO to reduce the risk of a recurrent stroke in patients with cryptogenic stroke before, qui is a type of stroke When medical tests can not identify the cause.

"The Amplatzer PFO occluder provides a non-surgical method for physicians to close a PFO," said Bram Zuckerman, M. D., director of the Division of Cardiovascular Devices at the FDA Center for Devices and Radiological Health. "Purpose as the device labeling clearly states, patients should be carefully evaluated by a neurologist and a cardiologist to rule out other causes known of stroke and help ensure that PFO closure with the device will likely help reduce the risk of a recurrent stroke . "

How does it work

The Amplatzer PFO occluder is inserted through a catheter placed in a leg vein and advanced into the heart. Here it is implanted near the hole in his heart between top right chamber (right atrium) and the left upper chamber (left atrium).

FDA said that the duties of devices can not be used in patients with an infection of the heart valves other infections untreated gold, gold heart tumor or blood clot in the implant site. The device is contraindicated in patients with other abnormal connection between heart chambers them or in which the anatomy or blood clots could interfere with the ability to move the catheter.

Assays for approval

FDA concluded device that demonstrated a reasonable assurance of safety and effectiveness after a Assessed randomized 499 participants aged 18 to 60 years who were treated with an Amplatzer PFO anticoagulants more drugs and compared with 481 participants who were treated with blood anticoagulant drugs.

While the rate of new beats in both treatment groups was very low, the FDA Said, the study found a 50% reduction in the rate of new stroke in participants who use the PFO Amplatzer occluder more drugs that thin the blood compared to those only take blood-thinning medications.

RAC US Exam Question No 44

Question No 44:

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA?

A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change.
B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location.
C. The change does not have to be reported because it is an OTC drug.
D. Not enough information.

Answer: D

ICH Proposes Two New Guidelines

The International Council on Harmonization (ICH) announced two new guidelines, with a (M9) to support the recommendations provided Biopharmaceutical Classification of drugs, while the other (M10) is applied to the validation of methods of bioanalysis and study no analysis sample preclinical and clinical studies.

The two new plans guidelines are part of efforts to harmonize regional differences in policy documents and were finalized by the ICH October 7. The publication of the guidelines document design and business plans on Thursday to continue the international expansion of the board last summer.

Biowaivers based on the Biopharmaceutics Classification system: M9

This proposed classification system that analyzes biopharmaceutical guide computer (BCS) based biowaivers is designed to help reduce the number and types of bioequivalence studies to be carried out, according to the targeted area / regional.

Currently, pharmaceutical companies must follow different approaches, particularly the United States, European Union, Japan, Canada and the World Health Organization at all times offer different advice, but overlapping biowaivers bioequivalence.

"Biopharmaceutics Classification System (BCS) biowaivers based computer may be applicable to BCS Class I and III drugs BCS but biowaivers basis for these two are not recognized worldwide classes," says ICH. "Also even the classification itself may be different. This means that pharmaceutical companies have different approaches in different regions."

ICH said that the main problems can be divided into information to support classification of drugs in one of the four BCS classes, and supporting information for the resignation itself.

The recommendations of the ICH guideline addressed:

• Supporting data for classification, treats, including solubility and permeability
• The data support a waiver, which could involve establishing criteria limits for dissolution of the drug is considered BCS BCS class I or III drugs

ICH said it expects to reach Phase 2 of the approval process of the Directive in the first half of 2018 STI, while approving the document Step 4 is likely to occur in the second quarter 2019

M10: Bioanalytical Method Validation

The new directive will provide recommendations on scientific regulatory requirements for the development of bioassays conducted during and biologics.

ICH bioassay defined as the quantification of drugs and metabolites in biological matrices His such as plasma, serum, blood, urine or other body fluids, which are performed in clinical and non-clinical studies.

EU, US and Japan have different regulatory guidelines or draft guidelines for validation of bioanalytical methods (BMV), which creates obstacles to the mutual use of data from bioassays in all regions.

The main technical and scientific issues can be classified BMV According ICH as method validation, analysis of the study sample and other issues. The recommendations outlined in the guidelines address issues taking into account the characteristics of the analytical methods used in bioassays, for example, the test and the chromatographic ligand binding.

ICH expect the adoption of the document Step 2 in the second quarter of 2018 and the adoption of the document in step four years later.

RAC US Exam Question No 43

Question No 43:

Which of the following federal laws includes information about ANDA submissions?

A. Antibiotic Amendments of 1945
B. Durham-Humphrey Amendment of 1951
C. Drug Amendments of 1962
D. Drug Price Competition and Patent Term Restoration Act
Answer: D

FDA, EMA Officials: Regulators Must Adapt to Effectively Regulate Precision Medicine

To effectively regulate medicine precision, regulators have to adapt to other testing methods produce, for example officials Food and Drug Administration US (FDA) and the European Medicines Agency (EMA) and the former President of medicines in the UK and Healthcare products Regulatory Agency (MHRA).

The call is made in a commentary published in the journal Nature Reviews: Drug Discovery Friday former president MHRA Alasdair Breckenridge, Third EMA medical officer Hans-Georg Eichler and Jonathan Jarow FDA, which serves as Senior Medical Advisor to the Director of Evaluation Center and drug research.

Specifically, the review authors say regulators should take into account factors through the generation of five key areas to test patient involvement, cost, access and security in order to advance the medical accuracy before risk.

Advances in medicine authors precision have allowed an approach in which genetic heterogeneity in patients and diseases can be used to optimize treatment by determining that patients see the most benefit, or larger risks of a particular treatment.

However, they argue that these advances also present a number of challenges that regulators face in order to facilitate further progress.

challenges

The authors argue that the advent of precision medical threat shake "the basis for regulatory decision making for the past 50 years," the randomized controlled trial (RCT).

In the development of traditional medicine, they say, ACE is considered the gold standard to support regulatory approval. However, precisely in medicine, the authors argue these tests "may not be possible," particularly in cases where a patient population is divided into several, often small, sub-groups.

In light of this, the authors argue that regulators must resort to other forms of evidence, such as adaptive clinical trials or observational studies of the wide range of digital data available through "electronic health records (EHR), patient records and the future of media, it can be social ".

However, the authors state that the use of these alternative methods should not completely replace ECR, "In our opinion, observational studies based on real-world data should complement and not replace ECR, and sometimes that can be the only source of information available, "the authors write.

The authors also argue that regulators should continue supporting a wider patient participation in making regulatory decisions.

"Instead of seeing patients as a large heterogeneous group, medicine precision offers the possibility of working with smaller populations needs of patients, more consistent and better informed to emergencies and potentially only they expressed clearly," write the authors.

For regulators, they say, then keep patient preferences in mind and the reported research results in other therapeutic areas such as oncology, which has traditionally focused on patient clinical outcomes reported.

Regulatory Recon: FDA Approves Humira for 10th Indication;

Regulatory Recon: FDA Approves Humira for 10th Indication; Unproven Stem Cell Centers Spreading Across the US (1 July 2016)

Headlines: US

• The clinics offer stem cell therapies unproved proliferate throughout the US (MIT Technology Review)
• copay coupons was making more expensive drugs? (ProPublica)
• FDA promises faster to the drug GMP warning letters shorter (Gold $ Detailed)
• Breakthrough therapies: FDA Official calls for greater transparency in nominations, Denials (Focus) ($ scriptures)
• Doctors, hospitals Americans paid billions for the drug, device manufacturers: the government (Reuters) (MassDevice)
• Fireproof: CRISPR takes the next step (bill Harvard Health)
• FDA warns Two Chinese medicines manufacturers for data integrity violations (Focus)
• Call for action on toxic chemicals (New York Times)
• A final medical school in the United States, even killed the animals to teach surgery. But no more. (Washington Post)
• The FDA issued new guidance on project Elemental Impurities (Focus)
• FDA approves Humira for non-infectious intermediate and posterior adults Panuveitis few weeks before Biosimilars Advisory Committee (Press) (Advisory Committee meeting)
• The difference between manufacturing and design defects (medications and right of the device)
• Reshaping the FDA Purpose To prepare the 'avalanche' of products cancer of senior officials (Forbes)
• The consequences for public health of updating the FDA to label drugs abortion (bio issues and blog)
• FDA approval at the barricade Place trajectory of the novel Cholesterol Drug (CardioBrief)
• More US babies with birth defects related Zika reported by the health agency (Reuters)

Headlines: International

• The final text travel by first impressions (MedicalDevicesLegal)
• Brexit: Guests find positives scientists (Financial Times)
• action plan to combat illegal therapies with fresh cells (Swissmedic)
• Swissmedic informs the risk of cervical cancer in women treated with Remicade and biosimilars (Swissmedic)
• AstraZeneca sells the rights to two dermatological drugs LEO Pharma (Reuters)
• WHO urges manufacturers to submit products for malaria prequalification scheme (WHO)
• UK regulatory approvals for testing medications stops cabinet of India (Reuters)
• Vaccine anti-couple found guilty in the death of young children should post on Facebook decision (vice)
• database sheds light on pharmaceutical payments to British doctors (Financial Times)
• Doctors want more details on labeling of biosimilars (GABI)
• Health officials to prevent yellow fever Congo career disaster (Reuters)

USA .: Pharmacy and Biotechnology

• International Supply Chain Pharmaceutical endangered as never before: Summary Webinar (FDA Law Blog)
• Top 5 winners and losers from Q2 2016 Biotech (Forbes)
• KaloBios emerges from bankruptcy, raises $ 14M in the recapitulation (fierce)
• NIH refused to march again in regulation and Human Challenge National Academies (Genomics Law Report)
• efforts by the NIH application uses scientific methods to reduce HIV transmission from mother to child (NIH)
• FDA to keep the workshop of PPE (BioCentury)
• Family history major predictor of heart attacks in people with psoriasis (Reuters)
• Advaxis manufacturing, security and development of key cancer drugs efficacy (BioPharmaReporter)
• Mother throws Serve daughter and others with poorly understood non-profit (Forbes)
• Update: The first clinical trials with live biotherapeutic: chemistry, manufacturing and control of information; Guidance for Industry (FDA)
• Bioequivalence recommendations paliperidone palmitate; Draft Guidance for Industry; Availability (FDA)
• Vulvovaginal candidiasis: drug development for treatment; Draft Guidance for Industry; Availability (FDA)
• Recurrent cold sores: the development of drugs for the treatment and prevention; Draft Guidance for Industry; Availability (FDA

United States: pharmaceutical and biotechnology products: results of clinical studies, documents and Designations

• The first patients included in the study post-approval Orberá US intragastric balloon (press)
• Phase III data: Merck KGaA Erbitux plus FOLFOX improved results in RAS wild-type metastatic colorectal cancer ($ PharmaLetter-)

Medical devices in the US:

• Turning FDA guidance Panels Project NGS (GenomeWeb)
• FDA panel for approval Medite OTC Factors Diagnosis of Infectious Diseases (detailed $ Gray)
• Sparo laboratories obtains FDA approval for its application connected monitor lung function, Ala (mobihealthnews)

United States: Assortment and government

• Warnings other prescription drugs making Preemption (Drugs and right of the device)
• PerkinElmer Faces game over 'Lousy' drug testing devices (Law360a- $)
• FDA fifth biennial report situation Judicious use of antimicrobials in food-producing animals (FDA)
• Federal Judge blocks law on abortion Indiana (Reuters)

Upcoming Meetings and Events

• Calendar of the Advisory Committee of the FDA
• Webinar - Update on the program of medical devices FDA clinical trials - July 14, 2016 (FDA)
• Provisional agenda: Part 15 Audience: Draft Guidelines for the regulation of cells, tissues or cell or tissue products based on September 12, 2016 (FDA)

Europe

• EMA: Strengthening interaction with the academic world (EMA)
• BIOTRONIK wins CE Mark for EDORA adaptive pacemakers MRI (MassDevice)
• Factors UK MHRA regulatory human Expectations Directive is aligned with the United States ($ CLINIC-)
• SRS Medical wins CE Mark for prostate Key stent (MassDevice)

Asia

• China expects the market for organic products in the fastest growing in the next decade (BioSpectrum)

India

• Torrent Pharma acquires Glochem unit in Vizag (Economic Times)
• Biosimilars are too expensive and do little to improve accessibility: Doctors (Economic Times)

Australia

• Fees and charges: Summary - July 1, 2016 (TGA)

Canada

• Draft Guidance Document - Canceling a Drug Identification Number (DIN) and notification of interruption marketing (Health Canada)

Zika

• The Zika fears are growing among women in the US ($ WSJ-)

General health and other interesting items

• US Transgender Estimated population doubles to 1.4 million adults (New York Times)

RAC US Exam Question No 42

Question No 42:

Devices that are exempt from premarket notification are:

A. All Class I devices
B. Some Class I devices
C. Most Class I devices and some Class II devices
D. All Class I devices and some Class II devices

Answer: C