Category Archives: FDA Press ReleaseThe following is a FDA Press Release concerning the safety of the nations food supply. It will either cheer you, or chill you. Bottom line— buy locally and in-season foods and a lot of the worry goes away.
FOR IMMEDIATE RELEASE
December 1, 2008
Media Inquiries:
Stephanie Kwisnek, [...]
Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
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Those of you who are regular readers know that I think Gardasil® is the wrong solution for preventing Cervical Cancer. It is my considered opinion that Gardasil® has one purpose — it is a much needed cash cow for Merck, in their time of financial need. My attempt at “Fair and Balanced” reporting is to [...]
FDA Releases Draft Guidance on Regulation of Genetically Engineered Animals
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On this page:
Genetic Engineering
Benefits of GE Animals
GE Animals Regulated Under New Animal Drug Provisions
The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) animals.
Although the guidance, released Sept. [...]
FDA News
FOR IMMEDIATE RELEASE
September 12, 2008
Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves Expanded Uses for Gardasil® to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and [...]
Potential Signals of Serious Risks
What is FDA posting?
The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that [...]
Goal Is to Provide Signs of Possibility Of Adverse Effects
By JARED A. FAVOLE
WSJ.com, September 5, 2008 8:07 p.m.
WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early [...]
FDA News
FOR IMMEDIATE RELEASE
May 28, 2008
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for [...]
FOR IMMEDIATE RELEASE
July 8, 2008
Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin [...]
Why is there resistance to the idea that coffee benefits your health?
Here’s why.
Almost thirty years ago researchers at Harvard University announced a connection between coffee consumption and cancer.
A few years later they retracted the study and recognized that the findings were flawed.
However, since that first study and the media frenzy that followed, coffee has been [...]
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