Heidi Gertner
Hogan Lovells
Articles
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USA - August 24 2022 On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions…
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…
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USA - February 12 2022 Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of…
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…
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…
