Prahsant Kumar Last week senior officials at FDA, including the FDA Commissioner, spent two full days listening and discussing their policy on regulation of off-label claims with stakeholders. The net result, no clear consensus and ongoing confusion about what the FDA may do next. About 70 speakers representing pharma and biotech companies, patient groups, industry lobbyists, and individuals presented a wide … Read more
Rapid information exchange using Twitter is getting increasingly popular among scientists for sharing articles and data leading to interesting outcomes as highlighted in a case presented in The Scientist. Genomics researchers attending a conference in Cambridge, UK, found out through a tweet that researchers from the Beijing Genomics Institute had publicly just released an unassembled sequence … Read more
In an obligatory article on the shocking presidential election results, let’s discuss the expected affect of the political upheaval on the pharma industry. It is purely speculative as nobody can say with authority what President Trump would do. The politics of the time does affect the regulatory environment. The good things first. Last eight years … Read more
Bias in clinical trial results is often suspected, particularly when the studies are not independently reviewed by regulators. Clinical studies are often conducted for marketing purposes with non-FDA regulated products such as food and supplements. In a review of clinical studies conducted to evaluate the link between consumption of soda and occurrence of obesity, it was found … Read more
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
