Rx Regulatory Puzzle: FDA’s 2015 Agenda Comes Together Piece By Piece
Generic drug labeling, drug shortages and compounding will be tackled in regulations in 2015; three documents weave together a picture of FDA’s upcoming actions on pharmaceutical-related rules.
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Companies must submit post-market safety reports electronically beginning in June 2015; waivers will be allowed, but they would only be temporary.
Five-point plan that calls for FDA to change definition of ‘labeling’ and ‘substantial evidence’ may offer hints as to what the next iteration of 21st Century Cures legislation will offer.