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- FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapsesThe U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
- Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meetingThe FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…