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FDA announced that in cases it is unable to conduct on-site Pre-Approval Inspections (PAIs), there are four possible outcomes for the applicants. This is to clarify a previous guidance document on the topic released last month. Applicants to plan and strategize accordingly. In a no-PAI situation, FDA may (1) approve the application, (2) issue a … Read more

Lying to FDA is a federal crime punishable by monetary penalties and jail time. We should never have to say that, but occasionally there are cases of people doing it anyway and becoming a warning for others. The case in point is of a team of clinical operations staff at a Florida CRO that fabricated … Read more

Even though both Pfizer and Moderna Covid vaccines have been administered to almost 200 million people in the US and many more worldwide, some populations have hesitated to get vaccinated due to them being only authorized under EUAs and not formally “approved”. There are two sides of the story; on one side, some people may … Read more

Paying patients to participate in clinical trials is common practice. Generally, these payments to clinical trial participants are justified to compensate for their time, inconvenience, discomfort, or some other considerations. Should a patient be paid higher for the increased perceived risk of visiting a clinic in the pandemic, or paid less because they are participating … Read more

If every time you heard about an FDA audit and you guessed it was about audit of drug manufacturing facilities, you guessed wrong. More than 80% of surveillance audits conducted by the FDA are at food facilities, compared to about 4% at drug facilities. There are many such surprising facts in a report on FDA … Read more

For several years, stem cell clinics in the US have flourished offering treatments to patients for all kinds of ailments, despite the FDA warning that these treatments are illegal under the US regulations. That ends on 1st June 2021 when FDA will finally initiate aggressive enforcement actions against such clinics, announced FDA’s Director for the … Read more

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