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Latest FDA News and Information

OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides

Today, the U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation?s (OtisMed) former chief executive officer, Charlie Chi, to 24 months in prison and also... read more

FDA approves new antiplatelet drug used during heart procedure

The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that... read more

FDA allows marketing of new device to help the blind process visual signals via their tongues

The Food and Drug Administration today allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people... read more

FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this draft guidance... read more

Federal Register: Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance ``Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.'' The purpose of... read more

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System

The FDA is Data Collection System proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act... read more

Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

When finalized this guidance will provide industry with an assessment paradigm for radiofrequency (RF)-induced heating on or near multi-configuration passive medical devices in the magnetic resonance (MR) environment, including... read more

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

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of... read more

Biologics Guidances

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

August 30, 2010 Clarification Letter - Afluria

clarify your pediatric study fulfillment requirements that were omitted from our approval letter, dated November 10, 2009

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