In an ideal world, regulatory policies and laws are based on unquestionable data from high quality scientific research but should there be other criteria or a standard for weighing unconventional data when the scientific data is not sufficient? There are numerous instances where claims of benefits by patient were not supported by the clinical trial … Read more
In one of its shortest guidance documents, FDA clarified that the highly coveted and tough to get Breakthrough Therapy Designation (BTD) can be rescinded for multiple reasons. The description of the conditions for rescinding BTDs are not new and have been defined in previous FDA documents, so the purpose of this new guidance is not … Read more
FDA has Systems Recognition Arrangements (SRAs) with Australia, Canada, and New Zealand, whereby it relies on the food safety assessments done by local regulators in those countries to avoid repeating the same by FDA inspectors. In theory, an SRA is a great way to assure quality of imported food, but because of its very limited … Read more
An analysis conducted by the US Preventive Services Task Force (USPSTF) found that dietary supplements are not effective in preventing or reducing the incidence of cardiovascular disease and cancer, and that supplements rich in beta carotene are indeed more harmful than beneficial. These conclusions, based on the pooled analysis of published clinical trial results, raise … Read more
Since the infamous case of Daraprim price gouging in 2015 where a drug company bought the rights to a drug with no generics and raised the price by 5000% overnight due to its monopoly, FDA has been publishing a list of approved drugs with no patent protection and no generic versions to encourage the industry … Read more
This week Amylyx’s ALS drug was approved by the Canadian regulators raising speculations that this would make it very hard for FDA to reject this drug despite the negative vote by the FDA’s Advisory Committee which based its recommendation on the underwhelming clinical trial data from the one pivotal trial conducted by the company. But … Read more
In the last two and half years, FDA has approved hundreds of EUAs for various products for the diagnosis, management, and treatment of Covid-19. However, EUAs are temporary permits to sell products which ends when the emergency is declared to be over, i.e., the emergency declaration is withdrawn. An appropriate market approval (510k, PMA, NDA … Read more
More than a year and half after the approval of the first two Covid vaccines, Novavax seems to be finally getting ready to secure its own EUA for its Covid vaccine, but is it too late to the market? The vaccines from Pfizer and Moderna have taken up a seemingly unsurmountable position in the market, … Read more
It took about 11 months from the beginning of the world-wide spread of Covid-19, in Jan 2020, to getting available an exceptionally effective vaccine to it. But this breakneck speed of development is an exception and should not be expected to be repeated for all other diseases and infections. The conventional wisdom of needing about … Read more
A report on inspectional findings during GCP audits by FDA and EMA inspectors found that both regulators found similar issues 9 out of 10 times. The findings of this report, published jointly by the FDA and EMA, support sharing of audit findings between the two agencies to reduce the burden of direct inspections for both. … Read more
