iwewlkws

Almost 14 years since the passage of the law requiring that results of clinical trials be posted within a year of trial completion, yesterday, FDA issued the first notice of non-compliance to a sponsor for violating the law, and promised stricter enforcement going forward. Ever since the creation of the clinicaltrials.gov online registry in the … Read more

Compounding pharmacies will be limited to distributing less than 5% of their compounded drugs out of the state in which they are physically located starting 27 October 2021. Many compounding pharmacies ship more than 50% of their compounded drugs out of state meaning these pharmacies will lose bulk of their business owing to the new … Read more

Yesterday FDA published the FDA 483 for Emergent’s vaccine manufacturing facility in Baltimore listing a litany of non-compliance findings made by its inspectors, and it points to the abysmal job done by J&J’s vendor validation team. Prior to giving a contract to a vendor it is essential that the client company conduct a thorough review … Read more

With wider vaccination and easing of mobility restrictions in the US, this is the time to restart clinical trials suspended or postponed last year due to the pandemic. But it may not be as simple; there are five areas of consideration for clinical trial restart. First, availability of human resources is still not at the … Read more

Yesterday, 14 April 2021, FDA released a new Guidance Document on remote audits, which could have been more appropriate in April of last year than now. While the GAO and other independent groups have been panning FDA for not conducting on-site audits, this guidance seems to push back hard by proposing that remote audits are … Read more

There are still about 50 vaccines for Covid-19 in Phase 1 clinical trials, and 77 in non-clinical development. Of the 86 vaccines in clinical trials, 23 have reached Phase 3 clinical trials the world over, 13 of which have been approved or authorized in at least one country. The Covid vaccine market is already quite … Read more

One of the casualties of the pandemic last year was the in-person meetings with FDA reviewers. For obvious reasons, FDA converted all its meetings since March 2020 to the virtual or phone call format as an alternate to in-person meetings on the FDA campus. Now, as the pandemic slowly winds down in the US, would … Read more

We often hear the manufacturer’s side of the FDA audit experience but not what happens internally at the FDA. A recently concluded investigation of a disagreement between an FDA inspector and his manager regarding his reports of non-compliance at manufacturing facilities by the Office of the Special Counsel provides a unique insight into FDA’s internal … Read more

Complaints by whistleblowers do not lead to automatic investigations by FDA and could take years for FDA to find credence. Many a times we know about whistleblower complaints to FDA that seemingly do not go anywhere as the alleged violators continue without any FDA investigations or negative consequences. There is no simple answers as to … Read more

Did the notification process, used as a precursor to filing an EUA for Covid diagnostic tests, help or hurt both the consumers and developers? A review of last years’ experience with the notification process for the EUA showed that FDA’s plan was poorly thought, knee-jerk reaction in the early days of the pandemic, and ended … Read more