HealthDay on MSN

FDA to review whether to allow more access to certain peptides

Key Takeaways Seven peptides that are now restricted will undergo U.S. Food and Drug Administration reviewHealth Secretary ...

FDA opens door to wider use of testosterone therapy for low libido

The FDA may allow broader access to testosterone therapy for men with low libido without known medical cause. Manufacturers ...
The American Journal of Managed Care

Global Gaps in Drug Access After FDA Approval: Insights From New Study and Ethics Guidelines

Lower-income countries rarely gain timely access to FDA-approved drugs tested in their populations, highlighting major global and ethical disparities. Physical access was defined as where a tested ...
Hosted on MSN

FDA launches real-time safety database for drugs and vaccines

WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a new centralized system that will allow scientists, regulators, and the public to analyze safety reports for drugs, vaccines, ...
PharmExec

FDA’s Shift Signals a New Era for Data-Driven Drug Development

Marking a fundamental shift in how we define acceptable clinical proof, it has indicated that one well-controlled trial, ...
Regulatory Affairs Professionals Society

FDA official: Data quality is key to plausible mechanism framework

A US Food and Drug Administration (FDA) official acknowledged significant regulatory hurdles in the development of products ...
BioSpaceOpinion

Opinion: For AI to have impact, the industry must align on data

As a drug moves through research and regulatory processes, any mistakes in the data will be compounded. Small gaps that a ...