Category Archives: FDA Clinical TrialsReporting any adverse events (unexpected side effects) to FDA after using a medical product, or other problems with any products that the agency regulates.
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On this page:
Tips for Reporting
Quick-Reference Chart for Reporting Problems to FDA
Types of Problems FDA Doesn’t Handle
Consumers play an important public health role by reporting to the Food and Drug […]
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 […]
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 […]
The use of beta blocker drugs before surgery to cut the risk of heart problems may be counter-productive, a study suggests.
Researchers found patients given the drugs were a third more likely to die within a month of surgery than those given a dummy pill.
Those on the blood pressure-lowering drugs also had double the risk […]
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 […]
The Secret History of the War on Cancer
By Devra Davis, PhD, MPH
Review by Leslie Botha, Holy Hormones Honey!
In a recent interview on CSPAN Davis stated, “For much of its history, the cancer war has been fighting the wrong battles, with the wrong weapons, against the wrong enemies.”
The Secret History of the War on Cancer by […]
Big Pharma Giants Schering and Merck
Take Heavy Criticism Over Vytorin Failure
This week Merck executives are very grateful for the revenue predictions for their blockbuster HPV vaccine, GARDASIL. Profits are predicted to climb from $300 million to $4 billion over the next year. After the Vytorin debacle —they’re going to need the cash.
So lock up your […]
There has been no increase in congressional appropriations to the FDA from fiscal years 1986 through 2006. (1)
FDA’s Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The […]
FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring
The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency’s oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency’s approach […]
Study reveals high infection rate in teens for virus linked to cervical cancer
Based on 60 study participants from three primary-care clinics in Indianapolis HPV rates reported in previous research have been underestimated. The latest study indicates four out of five sexually active adolescent females are infected with the human papillomavirus (HPV).
Human papillomavirus is a common […]
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