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 ...
RAPS

Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...
Nasdaq

ADMA Biologics Receives FDA Approval for Innovative Yield Enhancement Process, Paving the Way for Increased Production Capacity and Revenue Growth

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...

FDA to fast-track Regeneron drug facility in Saratoga County

The biotechnology company will use the federal pilot program for its planned $2 billion Saratoga Springs manufacturing campus ...
STAT

U.S. health officials inject new uncertainty into approval process for Covid boosters

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...
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 ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

The overlooked reason why new drugs take so long—and the $10 trillion fix

A new report estimates speeding up FDA drug approvals by one year could generate over $10 trillion in economic value from ...

Palvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules ...

A blood test that screens for multiple types of cancer? It may be available soon

The FDA could approve the first blood test that can detect multiple cancers, around the end of the year, setting the stage for it to become widely available.