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New FDA pilot offers expedited drug program sponsors expanded FDA meeting opportunities on manufacturing issues

USA - November 23 2022 Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing…

Ted Lis

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

USA - July 6 2022 On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional…

Heidi Gertner

FDA urges drug makers to establish risk management plans to reduce drug shortages

USA - May 31 2022 On May 19, the U.S. Food and Drug Administration (FDA or the Agency) published the draft guidance “Risk Management Plans to Mitigate the Potential for…

Lowell Zeta

FDA issues final guidance for importing drugs prior to anticipated approval

USA - March 8 2022 Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing…

Meredith Manning

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

USA - February 23 2022 The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors…

Meredith Manning