The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The Patient Advocacy Council, a Alabama-based commercial institutional review board (IRB), is disputing an FDA warning letter accusing it of failing to protect "economically and educationally disadvantaged subjects" in clinical trials it oversaw. Read More
FDA has barred all approvals for generic versions of Pfizer's Norvasc except for one issued earlier to Mylan, the agency announced in a notice to the U.S. District Court for the District of Columbia. Read More
The FDA should have more power to force manufacturers to make labeling changes and conduct postmarketing clinical studies, a trade association of leading insurers said in recent recommendations. Read More
Decisions on banning imported products can be based on a variety of factors, so companies must be prepared to challenge an import hold with the FDA, industry experts said at an FDAnews audioconference. Read More
The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More