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A new FDA pilot program to quickly advance gene therapies for rare diseases will use several elements of the Operation Warp Speed medical product development program for COVID-19 products, said CBER Director Peter Marks at the FDA Regulatory Education for Industry (REdI) Annual Conference on Monday. Read More
Novo Nordisk and BIOCORP have entered into negotiations for Novo Nordisk to acquire a controlling stake in BIOCORP, a French company which has been developing a Bluetooth enabled smart add-on device for insulin pen injectors. Read More
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, banning, however, all other drugs manufactured at the company’s Sanand, India, facility. Read More
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. Read More
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 to patients wherever they are — at home, at work, in cities or in rural communities. Read More
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 to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S. Read More
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 and request feedback from agency officials on device submissions under the Q-Submission program. Read More
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. Read More
Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines. Read More
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 of the False Claims Act. Read More
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 agency. Read More