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- BD advises recall of sodium chloride ampules in convenience kits after Huons Co. issueThe FDA issued an Early Alert after Becton Dickinson (BD) sent a letter to customers about a potential high‑risk device issue. The alert concerns convenience kits and procedural trays that contain…
- FDA updates guidance to clarify ANDA and 505(b)(2) approval pathwaysThe FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…