June 1, 2012 | Vol. 4 No. 22
Drugmakers increasingly face challenges in assessing whether an existing supplier contract is weak.
Drugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status.
CP Medical, a maker of suppository chelating products and other drugs, was handed an eight-page, 22-observation Form 483 after an inspection of its Huntington Beach, Calif., plant found inadequate validation, testing, control and reprocessing.
The U.S. Pharmacopeial Convention (USP) and the British Pharmacopoeia (BP) have developed two drug-product quality standards under a new, flexible approach that signals a drive toward speedier harmonization — and a potential break for drugmakers.
Branan Medical, a maker of drug testing kits, received an FDA closeout letter resolving myriad marketing clearance and manufacturing concerns cited in a 2009 warning letter.
Rogue online pharmacies looking to cash in on drugs in short supply are peddling counterfeit versions of Teva’s attention-deficit/hyperactivity disorder drug Adderall, the FDA warns.
The FDA is stepping up its handling of pharma and device cargo thefts, creating a cargo theft response team (CTRT) to assess companies’ action plans after a theft occurs.
The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report.
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