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When the FDA's Office of Combination Products (OCP) was established in December 2002, FDA Commissioner Mark McClellan described it as a significant step toward increasing the efficiency and timeliness of approving the complex products.
The FDA wants the manufacturers of OTC rectal drugs to add sodium content and warning information to labeling because the products have caused adverse events in people with certain medical conditions.
The FDA has issued a final rule establishing across-the-board content and warning labeling for thousands of orally ingested OTC drug products that contain certain levels of calcium, magnesium and potassium as active or inactive ingredients.
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).
The FDA’s Office of Generic Drugs (OGD) will soon post a dissolution-methods database on its website and start updating the Orange Book daily as part of an ongoing effort to help firms improve the quality of their generic drug applications.
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.
The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has told Corixa to immediately cease distribution of a promotional video for its combination cancer treatment and provide the FDA with a plan of action to correct misleading safety and efficacy claims made in the video.
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.
Tough regulatory restrictions on pharmaceutical sales practices, including expensive entertainment events, coupled with physician demand for more value, have forced drug manufacturers to look for new methods to gain access to physicians and remain competitive.