RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan products using expedited programs alone in combination to ...
JD Supra

Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, and Postapproval Evidence Generation

FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene therapies (“CGTs”): These draft guidances address ...
The Indianapolis Star

FDA-Authorized Expanded Access Programs Utilizing Jaguar Health’s Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with ...

The two programs are being conducted under separate Single-Patient Investigational New Drug (sIND) applications in the United States SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family ...
RAPS

FDA addresses establishment of inspection programs for injectables

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles. The 18-page draft guidance "addresses the ...
JD Supra

FDA Calls for Industry to Strengthen Recall Programs

On December 15, 2025, the U.S. Food and Drug Administration (FDA) issued a letter to industry emphasizing the importance of “effective recall compliance across the food supply chain” and reminding industry of their corresponding legal compliance ...