Regulatory Affairs Syndicator

FDA recently approved a vaccine for preventing rotavirus gastroenteritis in infants. The vaccine, called RotaTeq, is manufactured by Merck and Co.
RotaTeq is a liquid oral vaccine that’s given in three doses when the child is between the ages of 6…

FDA has issued a Public Health Advisory about reports of serious hepatotoxicity associated with the use of Ketek (telithromycin). Telithromycin is a ketolide antibiotic that’s used to treat respiratory infections, such as community-acquired pneumoni…

In December 2005, Boston Scientific recalled the company’s Flextome Cutting Balloon Monorail Delivery System, which is an angioplasty balloon with microsurgical blades attached to its sides.

These devices are being recalled because the catheter …

FDA recently issued a Public Health Advisory to remind health care professionals that the overuse of benzocaine anesthetic sprays can cause methemoglobinemia, a potentially life-threatening condition that can result in cyanosis, confusion, hemodynami…

Bristol-Myers Squibb is notifying healthcare professionals about new safety information for the company’s hydroxyurea capsules, sold under the brand names Hydrea and Droxia. Hydrea is used as an antineoplastic agent and Droxia is approved for treati…

Novartis has notified healthcare professionals about new warnings and drug information in the labeling for the antipsychotic drug Clozaril (clozapine).

Patients taking clozapine are at increased risk of potentially life-threatening agranulocytosi…

Baxter Healthcare and Cangene are alerting healthcare professionals about new warnings for WinRho SDF, an IGIV product used to treat patients with immune thrombocytopenic purpura (ITP).

In rare cases, ITP patients being treated with WinRho SDF h…

Consumers who have small children should be warned that in January 2006, a company called ?The First Years? recalled six styles of liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain Pseudomonas …

New York Times - Abortion rights advocates once hoped that RU-486 would prove at least as safe as surgical abortions and largely end the abortion wars by making access widely available and very private. But in the wake of reports in March that two more women had died …

New York Times - Abortion rights advocates once hoped that RU-486 would prove at least as safe as surgical abortions and largely end the abortion wars by making access widely available and very private. But in the wake of reports in March that two more women had died …

New York Times - Abortion rights advocates once hoped that RU-486 would prove at least as safe as surgical abortions and largely end the abortion wars by making access widely available and very private. But in the wake of reports in March that two more women had died …

The American Academy of HIV Medicine, the Human Rights Campaign, Lambda Legal, and the Gay and Lesbian Medical Association have issued a joint press statement in support of plans by the Food and Drug Administration to later this year discuss ending the nation’s barring of gay blood donors.

The Food and Drugs Administration of Pondicherry will initiate stringent action against the drug manufacturing companies which have not complied with Schedule M, from the middle of April 2006.

WASHINGTON - Saying “less is more,” a coalition of advertising and public relations groups wants to strip most of the warnings from prescription drug ads aimed at consumers.

Lexington Herald-Leader - WASHINGTON - Saying “less is more,” a coalition of advertising and public relations groups wants to strip most of the warnings from prescription drug ads aimed at consumers. Current direct-to-consumer advertisements “over warn and under inform …