We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
As part of the FDA’s pharmaceutical cGMP initiative, the agency has announced it will release a multicenter analysis of internal and international current good manufacturing practices (cGMP) requirements, as well as a draft guidance on modern quality systems.
Quality system failures at a New York-based ophthalmic imaging firm have prompted a warning letter from the FDA citing 14 different good manufacturing practice violations.
The FDA has accused Colorado-based TMJ Implants of failing to report a slew of incidents in which its dental joint devices were linked to serious injuries.
The FDA has yet to receive the required validation data from third-party single-use device (SUD) reprocessors regarding the cleaning, sterilization and functionality of reprocessed SUDs, prompting AdvaMed to raise new questions about the safety and effectiveness of the devices.
The FDA has issued a new report examining the challenges the U.S. medical products industry faces in developing cutting-edge products in a safe, effective and affordable manner.
A revised guide issued last week by the FDA may exempt drugmakers using advanced technologies to ensure batch quality from having to produce multiple validation batches before the initial distribution of a new drug.
A blueprint is emerging for an electronic track-and-trace system that follows pharmaceuticals in the U.S. drug supply chain and combats the counterfeiting of prescription drugs.
The FDA, in coming months, will release a multicenter analysis of internal and international current good manufacturing practices (cGMP) requirements and a draft guidance on modern quality systems, as part of the agency’s pharmaceutical cGMP initiative, a top official told DID.
As members of Congress and the Bush administration wage an intense rhetorical battle about reimportation, a flood of illegal prescription drugs is rushing through the nation’s mail facilities.
Drug manufacturers that use new, advanced technologies to ensure batch quality may not have to produce multiple validation batches before the initial distribution of a new drug, according to a revised guide released by the FDA this week.