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- FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networksThe FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
- FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kitsFDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…