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The FDA has issued a pharmacovigilance draft guidance that provides the foundation for a critical component of early postmarketing activities conducted by drug manufacturers, according to industry experts.
Drug manufacturers must decide whether compounding their products is a competitive advantage or disadvantage and then take action based on those decisions, according to a legal expert.
Citing a lack of industry input, the FDA has reopened the comment period for a notice on time estimates for collecting information for reporting manufacturing changes on approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
Generic firms seeking to market a version of King Pharmaceuticals’ muscle relaxant Skelaxin (metaxalone) are not required to list some prescribing information on the product’s label, said the FDA in a decision that clears a roadblock to generic competition.
As medical researchers develop safer and more effective ways to deliver site-specific drug therapies, the FDA can expect to receive a significantly greater number of applications for combination products that blur the line between the agency’s medical product centers, say experts.
The number of samples recommended by the FDA for testing in-process dosage units during tablet manufacturing is too high and would likely place a burden on firms, drugmakers told the agency in comments released last week on its powder blend uniformity draft guidance.
The FDA’s Obesity Working Group (OWG) has told the agency it should update an 8-year-old draft guidance on weight loss drugs to address newer long-term therapies and to advance an HHS campaign to alleviate the obesity epidemic in the U.S.
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a multicenter analysis of internal and international current good manufacturing practices (cGMP) requirements and a draft guidance on modern quality systems, as part of the agency’s pharmaceutical cGMP initiative, a top official told DID.
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.
The FDA is proposing a series of new initiatives to encourage drugmakers and academic institutions to collaborate with the agency to remove obstacles along the drug development path so that innovative new products can reach patients as quickly and as inexpensively as possible, the agency said in a report released yesterday.