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FDA approves AspireAssist obesity device

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FDA approves vaccine to prevent cholera for travelers

The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected... read more

FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous,... read more

Statement on HHS OIG Early Alert on FDA food recall initiation process

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Food and Drug Adminstration (FDA): CDRHNew

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN 130051 and DEN150007 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN 130051 and DEN150007 added)

Patient and Consumer Stakeholder Meeting Minutes, May 27, 2016

Medical Device User Fee Amendments 2017 (MDUFA IV)

Webinar for FDA Final Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - August 8, 2016

FDA will discuss this final guidance document at a webinar scheduled for August 8, 2016. The webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this... read more

FDA Voice blog: FDA Celebrates the 40th Anniversary of the Medical Device Amendments

In 1976, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”

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

Jobs at the Center for Biologics Evaluation and Research (CBER)

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010

Biologics Guidances

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016

Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2016.

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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