Pharmaceutical Commerce

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
Dermatology Advisor

FDA Moves Toward Faster Drug Approvals

FDA Commissioner Dr. Marty Makary and his top deputy, Dr. Vinay Prasad, detailed the plan Feb. 18 in The New England Journal of Medicine. The move is the latest in a series of FDA efforts to eliminate ...
The Munich Eye

FDA Revises Drug Approval Process to Require Only One Clinical Trial

Munich news, health insurance, technology, jobs and other topics for expatriates. The Eye Newspapers covers daily news and ...
GEN - Genetic Engineering and Biotechnology News

What the FDA’s Priority Voucher Decision Means for Psychedelic Drug Development

Psychedelic drug development can still benefit from the FDA Commissioner’s National Priority Review Voucher Pilot Program, though the CNPV designation was not given to Compass Pathways’ synthetic ...
Hosted on MSN

Taysha outlines accelerated BLA timeline for TSHA-102 with FDA Breakthrough Therapy designation and full global rights

CEO Sean Nolan stated, “The recent regulatory clarity and progress we've achieved, which was enabled by the strength of our REVEAL Part A data set, rigorous data evaluation methodology, and our ...
The American Journal of Managed Care

Postmarket Drug Safety Timelines Largely Unchanged After FDA Amendments Act

The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...
PharmExec

FDA Issues CRL to Disc Medicine for Eythropoietic Protoporphyria Treatment Bitopertin

Disc Medicine received a Complete Response Letter (CRL) from FDA for its New Drug Application (NDA) for bitopertin as a treatment for erythropoietic protoporphyria (EPP), delaying a potential ...