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Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

USA - October 18 2022 In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for…

Seth S. Ray, Jordan Carpenter, Jacqueline Harrington

FDA’s Proposal For Listing Materials on Medical Device Labeling: Considerations for Industry

USA - July 16 2021 On May 20, 2021, FDA’s Center for Devices and Radiological Health published a Discussion Paper entitled “Conveying Materials Information about…

Sheila L Birnbaum, Katherine Unger Davis, Sharon Turret

Litigation Risks in FDA Remote Interactive Evaluations

USA - November 1 2021 In March 2020, as the COVID-19 pandemic unfolded across the United States and around the world, FDA paused most foreign and domestic inspections in…

Julia Markham Cameron, Jonathan S. Tam, Marina Schwarz