Over the past week, the FDA issued final guidance on assessing credibility of computational modeling and simulation in medical device submissions and notifying FDA of a permanent discontinuance or interruption…
Two oncology drugs that hold the records for the longest-marketed accelerated approval cancer drugs without confirmed clinical benefit and safety profiles need shorter, more focused study in a subgroup, members…
In this edition of Quick Notes, we review marketing authorization for chlamydia and gonorrhea at-home sample collection kits, FDA guidance on notifying the agency of device discontinuances or interruptions, assessing…
An Arizona company marketing an unapproved vaginal contraceptive cream has settled a federal complaint and agreed to stop distributing the product until the company complies with the Federal Food, Drug,…
The FDA has published 40 new and revised product-specific guidances (PSG) which provide recommendations for developing generic drugs and generating evidence to support ANDA approvals. Source: Drug Industry Daily
A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for…
After almost a decade devoted to implementing unique device identifier (UDI) regulations, the FDA is now focused on enforcing them, says UDI expert Jay Crowley, a former FDA official who…
A company-initiated recall of nearly 68,000 Olympus bronchoscopes is now deemed class I by the FDA because of the risk of endobronchial combustion, which could cause serious injuries or death.…
FDA Commissioner Robert Califf said he believes the FDA can take steps to improve the current system for postmarket evaluation of drugs and make major renovations that address its current…
Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial…