JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: Sept 24th - Sept ...

Market opportunities include gaining a comprehensive understanding of FDA procedures for US pharmaceutical submissions, critical for navigating the largest global market. This course provides deep ...
Medscape

In the Race to the First Psychedelic Approval, Who’s Leading?

A new FDA regulatory pathway could accelerate approval of psychedelic therapies for resistant depression and PTSD, and ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: Malaysia’s NPRA starts recognition procedure pilot for drugs approved by FDA and EMA

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...
Houston Public Media

Psychedelic treatments are on the verge of FDA approval. Why Texas is pushing for them

Texas is helping shape the future of psychedelic therapies. Here's how they work and what access could look like.