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The FDA is seeking public comment from clinical trial sponsors, sites, investigators and other interested parties on a long-awaited revision of the International Council on Harmonisation’s (ICH) good clinical practice (GCP) guideline, ICH E6. Read More
Compliance with current good manufacturing practice (CGMP) has always been a top enforcement priority for the FDA. And lately, the agency has been taking a tougher stance on one particular CGMP area — process validation. Read More
The use of FDA’s checklist-like cover letter attachments for controlled correspondence and generic drug submissions are voluntary, the agency emphasized in a final guidance released Monday. Read More
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
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
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
Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines.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