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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

In an atypical move, many medical device companies are petitioning FDA to continue the 510k requirements for several Class II devices after FDA proposed that those devices are safe enough to not need such regulation and should be downgraded to 510k-exempt status. And in the process, the commenters exposed many holes in the current regulatory … Read more

Last year between March and December, FDA “reduced the need” for Pre-Approval Inspections (PAI) by more than 50%, and still met almost all its product approval timelines (93-100% of the times), raising the question if these inspections can be reduced for good. The year of the pandemic forced FDA to do an experiment otherwise impossible; … Read more

One year after the pandemic, there is still a critical shortage of laboratory supplies affecting most research activities indirectly. A survey of testing labs by the American Society for Microbiology in January found that supply shortages were affecting almost 50% routine bacterial testing, 35% sexually transmitted diseases, 30% mycobacteria, and almost 20% routine fungal tests. … Read more

It is ironic that on the first anniversary of the pandemic, we are worrying about how to deal with an excess of the vaccines. It may seem too early to discuss this, but it is not. While it is certainly good news that we will have sufficient vaccine to cover almost everyone in the world … Read more