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.
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
Beginning today, new safety and efficacy findings that emerge during postmarket clinical trials should be reported in periodic safety update reports (PSURs) submitted to the European Medicines Agency (EMA). Read More
A group of pharmaceutical representatives has recommended ten product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More
The European Medicines Agency has concluded a review of lax adverse event reporting at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More
China cleared the way for the U.S. Food and Drug Administration to add 10 new drug investigators to its local roster, following a Dec. 4 meeting between U.S. Vice President Joe Biden and Chinese President Xi Jinping. Read More
Drugmakers and the FDA have different ideas about the proper scale for the agency’s quality metrics program. While industry supports collecting data on no more than four metrics, the FDA promises only that it will monitor no more than 16. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
The FDA has handed Jubilant HollisterStier a warning letter for quality shortcomings at its Spokane, Wash., sterile drug manufacturing facility. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
HHS has approved the overhaul of the FDA's Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More