Headlines

Latest FDA News and Information

FDA approves Ragwitek for short ragweed pollen allergies

The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with... read more

FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids

In a safety communication notice issued today, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine... read more

Puerto Rico bakery agrees to stop manufacturing and distributing products

Los Genuinos, Inc., a Bayamon, Puerto Rico, food manufacturer, has agreed under terms of a court order not to process or distribute food until it addresses the unsanitary conditions found... read more

FDA approves Tanzeum to treat type 2 diabetes

The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Novel Influenza A (H7N9) Virus; Availability

The FDA is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (... read more

Federal Register: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance entitled "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices." National outbreaks of Toxic Anterior Segment Syndrome (TASS) have... read more

Evaluation of Automatic Class III Designation (De Novo) Summaries (K133883 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (K133883 added)

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

Summary Basis for Regulatory Action - ALPROLIX

Complete List of Currently Approved Premarket Approvals (PMAs)

Information updated through March 31, 2014

Complete List of Substantially Equivalent 510(k) Device Applications

Information updated through March 31, 2014

December 23, 2010 Approval Letter - Engerix-B

Subscribe!

Enter your e-mail address to get information about upcoming conferences from FDAinfo.com!


Newsletter preference:
HTML Text AOL