RAPS

Can Drug Development be Accelerated? FDA Wants Help

The US Food and Drug Administration (FDA) is soliciting input on how it might accelerate the development of certain drug products through the use of new and emerging biomarkers. In FDA's ...
Becker's Hospital Review

5 FDA moves shaping drug development, oversight

FDA moves shaping drug development and oversight include new gene therapy guidance, clinical trial transparency efforts, and recent drug approvals.
JD Supra

FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...
American Hospital Association

FDA fast-tracks the development of psychedelic medications following president’s executive order

The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to ...

FDA fast-tracks psychedelic drug research following Trump executive order

It's a big shift toward supporting psychedelic-based medicines for treatment-resistant depression, PTSD and substance use ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
Fierce Biotech

FDA celebrates progress to end animal testing but experts warn there’s still a long way to go

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission ...