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category archive listing Category Archives: FDA Approvals

FDA 101:

June 10, 2008 – 2:46 pm
Posted by H. Sandra Chevalier-Batik

How to Use the Consumer Complaint System and MedWatch

On this page:

Consumer Complaint Reporting
Reporting Problems Can Spur Action
MedWatch Reporting
How to Report to MedWatch
Problems to Report to MedWatch
Reporting Emergencies
FDA Consumer Complaint Coordinators (regions and telephone numbers)

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear […]

By H. Sandra Chevalier-Batik | Also posted in FDA Clinical Trials, FDA Press Release, Health Advisory, Take Action! | Comments (0)

The FDA Fails To Protect Patient Rights

June 7, 2008 – 7:21 am
Posted by H. Sandra Chevalier-Batik

The Food and Drug Administration should rethink its rejection of the Declaration of Helsinki.
Later this year, the US Food and Drug Administration (FDA) will adopt new standards for human clinical trials conducted without its advance sign-off in foreign countries. The rules will govern whether data from such trials can be used in applications to market […]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, FDA Clinical Trials, FDA Failure To Protect, FDA Press Release, Follow The Money | Comments (0)

A Guide to Drug Safety Terms at FDA

April 11, 2008 – 10:29 am
Posted by H. Sandra Chevalier-Batik

Inconvenient Woman readers know that I’m not an FDA fan.
In my opinion, the troubled agency’s close ties and financial dependence on Big Pharma
has been weakened its ability to perform its primary function — protecting the public. The FDA’s documented failure to impartially judge the veracity of drug trial results and enforce safety oversight of the […]

By H. Sandra Chevalier-Batik | Also posted in Big Pharma Watch, FDA Clinical Trials | Comments (0)

Deadlines May Affect FDA Decision Process

March 29, 2008 – 8:21 am
Posted by H. Sandra Chevalier-Batik

Analysis of decades of drug approvals by a Harvard Research team, published in the March 27th New England Journal of Medicine, provides the first scientific evidence of what many have come to suspect. Congress-mandated deadlines that control the FDA review of new medications may have “spurred a dangerous rush to judgment.”
Looking at drugs that have […]

By H. Sandra Chevalier-Batik | Also posted in Questionable Medicine | Comments (0)

FDA Identifies First Steps in Requirements for Safety Plans

March 28, 2008 – 12:19 pm
Posted by H. Sandra Chevalier-Batik

FDA News

FOR IMMEDIATE RELEASE
March 27, 2008

Media Inquiries:
Chris DiFrancesco, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
New FDAAA requirements being implemented
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required […]

By H. Sandra Chevalier-Batik | Also posted in FDA Press Release | Comments (0)

FDA To Review Merck’s Application To Expand HPV Vaccine Gardasil’s Approval To Older Women

March 27, 2008 – 11:22 am
Posted by H. Sandra Chevalier-Batik

FDA has granted priority review status to Merck’s application to expand marketing of its human papillomavirus vaccine Gardasil to women ages 27 to 45, the company said Wednesday, Reuters reports. The designation means that an FDA decision could come within six months, according to Reuters. currently is approved by the FDA for use by […]

By H. Sandra Chevalier-Batik | Also posted in HPV Infection | Comments (0)