FDA Related News

Opportunities, Risks in SCOTUS End to Chevron Deference: Lawyers

Attorneys in several law firms analyze the opportunities and risks for FDA-regulated companies arising from the Supreme Court decision to overturn Che...

Web Site Illegally Selling Semaglutide Products: FDA

FDA warns the ozempen.com Web site to stop offering unapproved and misbranded drugs to U.S. consumers.

Human Drugs

FDA OKs New Lilly Alzheimers Drug

FDA approves Lillys Kisunla injection to treat Alzheimers disease.

Plan Now to Adopt FDA Trial Diversity Guide: Lawyers

Five Hogan Lovells attorneys analyze a new FDA draft guidance on clinical trial diversity action plans and urge companies to begin planning now to imp...

Human Drugs

ICH M14 Pharmacoepidemiological Studies Guide

FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational pharmacoepidemiologic...

Medical Devices

Device Total Product Life Cycle Advisory Program Continues

CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the Division of Ophthalmi...

Guidance on Addressing Regulated Product Misinformation

FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical products.

Human Drugs

Guide on Combo Product Risk Analyses

FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.

Drug Delivery Device Guidance

FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...

Medical Devices

Philips Updates BiPAP Ventilator Use Instructions

FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.