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Last month’s approval of Sarepta’s drug for Duchenne Muscular Dystrophy (DMD) by FDA shook the regulated industry due to the extremely arbitrary nature of the FDA decision. The review of the summary basis of approval, which lists the data FDA relied on to approve this drug, would not help. So, should all developers of products for … Read more

Last year FDA’s newly formed Office of Pharmaceutical Quality (OPQ) announced that it would update its GMP inspections process to add risk-based factors whereby sites with higher risk will be given more attention and sites that exceed basic compliance will be rewarded. The program which was named New Inspection Protocol Project (NIPP) would change the regulatory paradigm of GMP inspections by … Read more

The Priority Review Vouchers or PRVs are a much coveted incentive from FDA with an estimated value of over $300 million, but a close review of the case studies shows it may be more hype than benefit to the owners. It has been almost 10 years since the PRV program was implemented and so far 11 of these were … Read more

In recent years, FDA has reversed its policy of enforcement discretion for several products whereby certain products were regulated less due to lower perceived risk. Two of such cases have garnered wide-spread criticism. Late last year, FDA released several new guidance documents to create new stricter rules for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). … Read more

Not surprisingly, a report in BMJ last week said that most reviewers find jobs in the regulated industry after leaving FDA. The authors of the report raised conflict of interest concerns regarding the so-called “revolving door” between FDA and industry. However, a close review of the existing policies at FDA show that such concern is unfounded. FDA … Read more

An analysis of published and unpublished adverse events reports from clinical trials shows that much of the adverse event data is not published in peer-reviewed journals. The authors concluded that peer-reviewed journals are not a reliable source for all adverse events identified for a given drug. The authors recommended that interested parties should look at other sources … Read more

This week the Chinese FDA announced results of its year-long investigation into clinical trials conducted in China, and the results were appalling. But its impact on Chinese manufactured drugs sold in the US is likely minimal, at least in the near future. Chinese auditors found that more than 80% of clinical trials contained fabricated and fraudulent data, … Read more

News in the past week has been rife with another drug company gouging the price of a critical life-saving drug with no apparent reason. In a span of 6 years, Mylan raised the price of its EpiPen by 400%, and once again we had all those debates of how pharma companies profit from artificial monopolies and … Read more

Last week, NIH released the final rule for registering clinical trials and reporting results for completed studies. The most important part of the final rule is regarding the submission of results from completed clinical trials. Starting 18 Jan 2017, all completed clinical trials will be required to submit results on clinicaltrials.gov within 1-3 years of study completion … Read more

The first stage of the implementation of the Food Safety Modernization Act (FSMA) officially came into effect this Monday (19 Sep 2016) whereby all large food manufacturers, with 500 or more employees, have to be in compliance with strict food quality and contamination prevention standards. The food GMP regulations require manufacturers to control all aspects of growth, … Read more