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The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
The number of drug recalls shot up 17 percent in 2013 compared to 2012, despite the FDA’s best efforts to promote quality-by-design programs and upgrades to facilities. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
The FDA is maintaining pressure on Pfizer subsidiary Meridian Medical Technologies, a maker of drug auto-injectors, to improve quality at its Missouri plants. 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
Sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, manufacturing plant. 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
Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More