Tag: fda

Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions ...

Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President ...

About one in eight women in the United States experiences postpartum depression after giving birth. Soon, there may finally be ...

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits ...

Based on recent regulatory changes at the state and local level and the efforts by the federal government and certain ...

On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the ...

FDA Issues Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance - Life Sciences Perspectives FDA Issues Artificial Intelligence/Machine Learning ...

US Supreme Court Justice Samuel Alito on Friday stepped in to temporarily block lower courts’ decisions to impose restrictions on mifepristone, a ...

The Long (Un)Winding Road Part 2: FDA’s Final Transition Guidances for COVID-19 Devices - Life Sciences Perspectives The Long (Un)Winding ...