Emily Van Tuyl
Dechert LLP
Articles
Results 1 to 3 of 3
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…
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…
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…
