Raps

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy (CGT) products.

Using the US Food and Drug Administration's (FDA) plausible mechanism framework to allow for greater use of causal inference may help with evidence generation for rare diseases, according to a recent paper published in The Journal of Clinical Investigatio

The European Medicines Agency (EMA) is holding a consultation about a draft framework intended to cut the time it takes to implement data standards.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices suggests the need for greater postmarket surveillance, accordi

Today In Hip Hop History: The Last Episode Of 'Yo! MTV Raps' Aired 31 Years Ago The Last Episode Of 'Yo! MTV Raps' Aired 31 Years Ago

RAPS Collaborative Communities bring together regulatory and quality professionals who share common specialties, challenges, and interests. These groups foster deeper learning, targeted discussions, and meaningful collaboration.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified logbooks to the agency. The agency also warned two other OTC firms for multiple violations of good manufacturing p