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FDA Statement on Approvable Letter to Inamed Corporation for silicone gel-filled breast implants (September 21, 2005)

The U.S. Food and Drug Administration (FDA) today issued an approvable letter to Inamed Corporation for its premarket application (PMA) for silicone gel-filled breast implants. Federal law and regulations prohibit the government from discussing the specific contents of the letter.

FDA Approves First Pediatric Generic AIDS Drug for U.S. Marketing(September 19, 2005)

The U.S. Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today announced the approval for marketing of several generic versions of drugs that treat HIV, the virus that causes AIDS.

Theresa A. Toigo Is Appointed Acting Director of FDA’s Office of Women’s Health (Sept. 16, 2005)

U.S. Food and Drug Administration Commissioner Lester M. Crawford today announced the appointment of Theresa A. Toigo as the Acting Director of FDA’s Office of Women’s Health. Ms. Toigo also serves as the Director of FDA’s Office of Special Health Issues (OSHI).

FDA Releases Results of Study on Defibrillator and Pacemaker Malfunctions Part of Agency Drive to Improve Device Safety Monitoring and Public Communications
(Sep .16,2005)

In its ongoing commitment to improve the safety monitoring of implantable cardiac devices and provide earlier notice to doctors and patients of potential problems, the U.S. Food and Drug Administration (FDA) released its retrospective review of malfunctions of implantable cardioverter defibrillators (ICD) and pacemakers occurring from 1990-2002. The findings were presented today at the Heart Rhythm Society “Policy Conference on Pacemaker and ICD Performance,” in Washington, DC.

FDA Proposes Rule on Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs(Sep. 15, 2005)

The Food and Drug Administration (FDA) today is announcing a proposed current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs. The regulation, which establishes minimum standards for the production and testing of PET drug products, is intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, identity, strength, quality, and purity.

FDA Amends Interim Final Rule “Use of Materials Derived from Cattle in Human Food and Cosmetics” (Sept. 6, 2005)

The U.S. Food and Drug Administration today published several amendments to the July 2004 interim final rule, “Use of Materials Derived from Cattle in Human Food and Cosmetics,” that will allow the use of certain cattle-derived material in human foods and cosmetics.

National Mammography Quality Assurance Advisory Committee(Sep26&Sep27of 2005)

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee

The FDA Safety Information – 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

nformation on the FDA safety information and adverse event reporting program

FDA gives Notice to Food Industry about the Safety of Food Affected by Hurricane Katrina

A Notice From The Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products About the Safety of Food Affected by Hurricane Katrina

FDA Information About Generic Drugs

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug.

Approvals of FDA-Regulated Products

FDA’s regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers

FDA issues a Public Health Advisory on the Fentanyl Patch.

FDA is investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product