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FDA approves new treatment for rare form of hemophilia

The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [... read more

FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic

The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to... read more

FDA approves Ofev to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

FDA approves Esbriet to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

Food and Drug Adminstration (FDA): CDRHNew

Summary Information for: EverFlex Self-Expanding Peripheral Stent System

Labeling, Approval Order, and Summary of Safety and Effectiveness for EverFlex Self-Expanding Peripheral Stent System (P110023S007).

Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance

The FDA is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens... read more

Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff (PDF - 266kb)

Nucleic acid-based in vitro diagnostic devices for the detection of MTB-complex and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens are qualitative nucleic acid-based devices that detect... read more

Class I Medical Device Recall: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes ? Electrodes will Not Work with Philips FR3 and FRx Automated External Defibrillators (AEDs)

These defibrillation electrodes have been recalled because Philips made changes to the design of their connectors for the FR3 and FRx AEDs. Because of these changes, the Covidien defibrillation electrodes... read more

What's New: Vaccines, Blood & Biologics RSS Feed

Draft Guidance for Industry-Providing Submissions in Electronic Format ? Postmarketing Safety Reports for Vaccines

Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the... read more

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