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 ...
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The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible ...
Hosted on MSN

FDA approves multiple breakthrough devices and programs in one week

In a landmark week for medical innovation, the FDA approved or cleared multiple breakthrough technologies, from the first gene therapy for genetic hearing loss to a wireless brain implant trial for ...
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 ...
Corpus Christi Caller-Times

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

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...
Hosted on MSN

FDA declines to issue specific guidance on health programs' foreign drug imports

The Food and Drug Administration responded to a health policy group requesting clear enforcement of alternative funding programs, or AFPs. The agency reiterated its regulation against the foreign ...
JD Supra

Staying on TEMPO: Five Things for Digital Health Companies to Know About the FDA’s New Pilot

Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care. Through the Centers for Medicare and Medicaid (CMS) ...
MarketWatch

Regenxbio Shares Plunge on FDA Pausing Two Drug Development Programs

Shares of Regenxbio plunged after the Food and Drug Administration placed clinical holds on two drug development programs after a five-year-old participant in one study developed an intraventricular ...
National Academies of Sciences%2c Engineering%2c and Medicine

Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration

In addition, the FDA regulates medical devices, veterinary drugs, food and food additives, and cosmetics and has special programs to encourage drug development for rare diseases and for children and ...