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FDA offers new guidance on charging for investigational drugs

USA - August 24 2022 On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions…

Robert Church

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…

David Horowitz

FDA invites comment on guidance on meetings with OTC sponsors

USA - February 12 2022 Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of…

David Horowitz

Meta ban on health-targeting ads will soon restrict clinical trial recruiters

USA - January 12 2022 A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms - which includes restricting…

Robert Church, Sally Gu, Meredith Manning, Ron Wisor

FDA seeks comments on how to transition approved drug products to device status under Genus

USA - August 13 2021 On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C…

Jason F. Conaty, Randy Prebula