Tag: FDA

FDA Urged to Bar Psoriasis Drug

A federal panel of dermatologists has asked the FDA to avoid approving Tazoral (Allergan), a medication for treating moderate-to-severe psoriasis because of concerns about birth defects and weakened bones. discount drugs canda

The drug’s active ingredient, tazarotene, is available as a gel and a cream. The FDA will be considering the panel’s vote when it decides whether to allow the tablet form of the drug in the U.S.

FDA: Monitoring Drug Safety

Drug Safety

DHHS Secretary Michael Leavitt and Acting FDA Commissioner Lester M. Crawford unveiled a new vision for the FDA that they hope will promote a culture of openness and enhanced oversight within the agency.

The agency plans to create a new independent Drug Safety Oversight Board (DSB) to review the management of drug safety issues within the Center for Drug Evaluation and to provide emerging information to health providers and patients about the risks and benefits of medications. (See Dr. Stefanacci’s commentary on page 176.) official canadian pharmacy

As the FDA develops new communications formats, it will be soliciting public input on how it should manage potential concerns associated with disseminating emerging information prior to regulatory action. The agency will issue draft guidance on procedures and criteria for identifying drugs and information for its Drug Watch Web page.

Entecavir Gains FDA Approval

Entecavir Gains

The FDA has approved entecavir (Baraclude™, Bristol-Myers Squibb) for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This oral antiviral therapy is designed to block the replication of hepatitis B virus in the body by interfering with the ability of the virus to infect cells.
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FDA Head Leaves

FDA Head Leaves

Lester Crawford, 67, has suddenly resigned as head of the FDA, saying that he was stepping aside because of his age. The new acting commissioner is Andrew von Eschenbach, a urological surgeon previously with the University of Texas MD Anderson Cancer Center and the National Cancer Institute.

His three-year tenure at FDA was marked by increasing criticism and a troubled past year. The painkiller Vioxx was pulled off the market for safety problems, and he indefinitely postponed non-prescription sales of emergency contra­ception over the objections of staff scientists who had declared the pill safe. The FDA’s women’s health chief resigned in protest.
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Dr. Crawford had been elevated by President Bush from acting commissioner partly because his experience was deemed important as the FDA tried to better safeguard the food supply against bioterrorism.

FDA Creates Panel For Consumers

A new FDA panel has been formed to educate consumers about the risks of taking medications. canadian pharmacy viagra

The Risk Communication Advisory Committee will comprise 15 experts and patient advocates who will communicate safety information on drugs, medical devices, and other regulated products. The panel’s initial charter will last two years.