The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing subjectivity into what should be an objective process.

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new information from the trial, the framework allows researchers to incorporate preexisting data at the outset, including details about drug performance gathered from earlier trials, or predictions based on similar drugs.

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

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

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 pertain to critical tracking events across the supply chain,

The proposed recommendations are intended to safely expedite approvals of promising therapies for multiple myeloma, but one expert is skeptical about the likelihood of industry compliance.

FDA draft guidance could speed approval of individualized genome editing and RNA therapies for rare diseases.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

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.

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.