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FDA Requires “Patient-Decision Checklists” for Breast Implants: What Could This Mean for Industry?

USA - November 22 2021 The FDA announced on October 27, 2021, that it will restrict the sale of breast implants to healthcare providers and facilities that use a…

Katherine Unger Davis, Justin M. Kadoura, Marina Schwarz, 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, Marina Schwarz, Emily Van Tuyl