It has been required since 1998 that race and ethnicity information be presented with clinical trial results included in market approval applications for all FDA-regulated products. However, there exists signification confusion about the specific demographic sub-groups that should be collected and the standardized approach that should be followed leading to variability in the reported data. … Read more
In a change more than 20 years in the making, the FDA released the final rule for good manufacturing practices (GMP) for medical devices this week. Although most of the changes incorporated into the final quality systems (QS) regulations have been practically implemented through various policies over the last decade, the final rule contains a … Read more
The FDA announced a major reorganization of its Office of Regulatory Affairs (ORA) which currently leads all FDA audits, litigations, and enforcement actions to reorganize its staff involved with food facility inspections from those involved in drug, biologic, and medical device inspections. The regulated industry needs to be aware of this reorganization, even though the … Read more
About 2 months after the first public reports of T-cell cancers linked to CAR-T therapies, the FDA finally decided to put a Box warning on all approved CAR-T therapies for unexpected malignancies. At the same time, the FDA also raised new expectations from CAR-T therapies in development, particularly those for indications outside hematology and oncology. … Read more
Informed consents from patients/subjects are critical both in clinical care and clinical trials. However, informed consents are mostly written such that it would be hard for most patients to adequately understand them leading to improper informed consent. A study published this week reports on the experience of a clinical practice using ChatGPT to write/revise informed … Read more
This week the FDA released its annual report on compliance inspections listing key observations made by its inspectors, giving current trends in non-compliance activities and related FDA enforcement activities. The report provides an overall picture of what FDA inspectors look for at the facilities they are auditing to help others prepare for the FDA inspections. … Read more
FDA publishes a lot of guidelines to assist the industry, on its website. But since FDA’s website has more than a million pages, by some accounts, finding all relevant documents on the FDA’s website is no easy task. To make it easier for GMP manufacturers, the FDA published a new page on its website with … Read more
Under the Modernization of Cosmetic Regulations Act of 2022 (MoCRA), cosmetic manufacturers are subject to increased registration and GMP compliance rules. This week FDA released several electronic tools to assist cosmetic manufacturers in submitting information required under MoCRA. These include electronic forms for providing manufacturer information, product listing, and other commitments expected to be submitted … Read more
Last year’s biggest drug was semaglutide, the weight-loss drug marketed by Novo Nordisk as Wegovy and Ozempic. Both these drugs are currently in shortage which means that compounding pharmacies are allowed to compound them from active ingredients on prescription, and they have been. Novo pushed back by filing patent infringement lawsuits against a few compounding … Read more
It has become an annual ritual for FDA to release several new Guidance Documents in the last few days of a year and true to that, the FDA did exactly that by releasing 21 new Guidance Documents in the last 13 days of December. Many of these Guidance Documents affect critical aspects of FDA regulated … Read more
