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Drug companies do not have to include stability data on undistributed reprocessed batches that are not typical of batches produced by the approved manufacturing process in annual reports to the FDA, according to the Division of Manufacturing and Product Quality (DMPQ).
The FDA has revised storage stability testing of new drug substances and products, and products packaged in semipermeable containers, to accommodate climates that have higher humidity, the agency announced in a pair of revised guidances that went into effect in late November.
FDA authority will be tested for the first time under the 1994 Dietary Supplement Health and Education Act (DSHEA) in March as the agency girds itself against court challenges from supplement makers when a U.S. ban against ephedra goes into effect.
In its first challenge to ban the sale of a dietary supplement under the 1994 Dietary Supplement Health and Education Act (DSHEA), FDA announced Tuesday it will issue a final rule to prohibit the sale of dietary supplements containing ephedra.