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Promising treatments are provided preferential review options in several regulatory domains. This week Australia’s Therapeutic Goods Administration (TGA) joined regulators in US, Canada and Europe in creating two expedited approval pathways for promising drugs, namely, the Priority Review and Provisional Approval designations. The Priority Review process is similar to that at the FDA where the eligible application will be … Read more

Not many people know that FDA has an Emerging Sciences Working Group (ESWG) for the last year consisting of 15 leaders from various departments who brainstorm about innovative new technologies being developed but have not yet reached FDA review stage. All new innovations start as ideas which over time evolve through development and testing to product that … Read more

This week FDA released a new form specifically designed for whistleblowers in the medical device industry. Anyone can report alleged regulatory misconduct directly to FDA. The kind of misconduct FDA is looking for are failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow GMP, or off-label promotion. The examples cited by … Read more

Earlier this month, actor Ben Stiller announced that he was free of prostate cancer thanks to a routine PSA test he got. His essay encouraged all men to get PSA tests. However, the U.S. Preventive Services Task Force (USPSTF), a voluntary non-profit that makes recommendation for screening tests, does not recommend PSA tests due to very high false positive … Read more

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