Twenty-five drugs manufactured by Intas Pharmaceuticals have been excluded from an FDA import alert because they are in short supply, the agency wrote in a June 2 import alert letter,…

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

Drug shortages continue to plague the U.S. healthcare system — a longstanding problem exacerbated by COVID-19-related trade interruptions, natural disasters, and ever-changing political landscapes. Source: Drug Industry Daily

As part of the FDA’s effort to increase access to home-use medical devices, CDRH is seeking comments from devicemakers, researchers, clinicians and the public on how to bring healthcare directly…

Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data…

The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential…

Medical device manufacturers should prepare now for the potential disruption in fluctuating power, contaminants or unusual levels of heat or humidity that often occur during hurricane season, the FDA advises.…

Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines. Source: Drug Industry Daily

The U.S. Supreme Court on Thursday sent back to a lower court two cases involving a pair of supermarkets accused of overcharging the federal government for prescription drugs in violation…

Medicare will pay for treatment with any antiamyloid antibody that is fully approved by the FDA and administered as part of a national registry run by CMS, according to the…