FDA Related News

Human Drugs

ICH Pediatric Extrapolation Guidance

FDA publishes the International Council for Harmonization E11A guidance intended to recommend and harmonize pediatric extrapolation in developing new ...

Medical Devices

FDA Clears Nanox AI Cardiac Solution

FDA clears the Nanox HealthCCSng V2.0 artificial intelligence coronary solution to help detect coronary artery calcium.

Over 1,000 BIMO Inspections in FY 2023

An FDA report on bioresearch monitoring FY 2023 metrics documents nearly 1,100 inspections through FDAs five Centers.

Human Drugs

Novartis Wins Generic Entresto Approval Stay

The United States Court of Appeals for the DC Circuit grants a Novartis motion to stay FDAs approval of MSN Laboratories generic version of Novartiss ...

Federal Register

Pennsaid Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Horizon Therapeutics Pennsaid (diclofenac sodium) topical solution 2% was not withdrawn due to safety or ...

Federal Register

ANDA Product-Specific Meeting Request Guide

Federal Register notice: FDA makes available a final guidance entitled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA....

Biologics

J&J Combo Approved for Lung Cancer

FDA approves a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of certain adult patient...

Medical Devices

FDA Clears SI-Bone Pelvic Fracture Implant

FDA clears a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusion.

Human Drugs

FTC Supports FDA Draft on Interchangeable Biosimilars

The Federal Trade Commission says it supports an FDA draft guidance easing the approval requirements for interchangeable biosimilar drugs.

Medical Devices

GAO Sees Actions, Challenges in Device Surveillance

The Government Accountability Office says FDA has faced challenges in its preparations for beginning active postmarket surveillance of medical devices...