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As the pandemic recedes in the US, FDA management seems to be having the same issue practically all managers in the country are facing; do we bring workers back to the offices or keep working remote? It seems FDA is leaning towards keeping it remote. In a public presentation earlier this month, the new Director … Read more

The pandemic necessitated remote clinical trials where almost all the trial activities were done at the home of participants rather than in clinics. Remote clinical trials while being quite efficient and productive raise new questions about data integrity and reliability. How does one monitor data collected and submitted by the patient remotely? Several trial specific … Read more

South Korea was one of the first countries to curtail the spread of Covid infections and bring the pandemic under control. A report by the FDA comparing the responses by the government agencies in the two countries presents starkly different approaches between the two countries despite having similar timelines. While the health agencies in South … Read more

Almost all the products used to diagnose, prevent, and treat Covid infection, in the US, were authorized under the Emergency Use Authorizations (EUA), and now that the pandemic seems to be getting under control, at least in the US, it is critical that manufacturers of these products start thinking of life after the emergency both … Read more

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