BioSpace

FDA’s Bespoke Pathway To Focus on Gene Editing and RNA-Based Treatments for Rare Diseases

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...

Rare disease pharmas could benefit from FDA guidance to accelerate development

FDA draft guidance could speed approval of individualized genome editing and RNA therapies for rare diseases. Read more here.

FDA fleshes out new roadmap for testing personalized therapies

At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.
Medscape

FDA Changes Drug Trial Guidance: Experts Take Sides

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
National Law Review

FDA Announces New Guidance and Exemptions Under Food Traceability Rule

The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...
Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

New FDA guidance that’s a ‘huge deal’ for clinical trials

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...
STAT

New FDA guidance for antibiotic use in food-producing animals prompts criticism over antibiotic resistance

New FDA guidance on the use of antibiotics in food-producing animals has prompted criticism that it fails to consider the impact on human health.