Regulatory Affairs Syndicator

We have been waiting for continuous glucose monitors to be available in the market.

Lexington Herald-Leader - DENVER - Colorado lawmakers approved and sent to the governor on Friday a measure that would allow women to go straight to a pharmacist to get the morning-after pill. Currently in Colorado, Plan B, as the emergency contraceptive is called, requires a …

MAHWAH, N.J.—-March 31, 2006–Representatives of DOBI Medical International, Inc. recently met with a panel of independent Chinese physicians to review its ComfortScan® system clinical trial data resulting from a clinical study the Company completed in Beijing, China pursuant to a protocol developed with the Chinese State Food and Drug Administration .

On March 9, 2006, the United States District Court for the Southern District of New York entered a Consent Degree that permanently enjoins Canada Care Drugs, Inc. (Canada Care), Christine Ruggiero, and Claire Ruggiero (defendants) from causing the importation of drugs, receiving commissions from the importation of drugs, and advertising or promoting any drug importation service.

The Food and Drug Administration said Friday it has approved generic Retrovir capsules to treat HIV. The agency said it has cleared for the U.S. market zidovudine in capsule dosage form, the generic version of GlaxoSmithKline’s Retrovir, which recently went off patent.

Genentech Inc. and partner Biogen Idec Inc. said Thursday they turned in a supplemental use application for Rituxan, their lymphoma drug, to the Food and Drug Administration.

TORONTO (CP) - MDS Inc. (TSX:MDS) said Friday it is temporarily shutting down bioanalytical operations at a Montreal plant to focus on the speedy resolution of a regulatory review with the U.S. Food and Drug Administration.

Belleville News-Democrat - 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 …

Kait 8 - WASHINGTON Advertisers say their audience is becoming increasingly weary of prescription drug commercials that “over warn and under inform.” A coalition of advertising and public relations groups is applying to the Food and Drug Administration to …

WASHINGTON (AP) — Advertisers say their audience is becoming increasingly weary of prescription drug commercials that “over warn and under inform.” A coalition of advertising and public relations groups is applying to the Food and Drug Administration to strip most warnings from drug ads.

Revenue decline drops Cardiome Pharma to $8.6M Q4 loss from $1.8M …Calgary Sun, Canada - 1 hour ago… (TSX:COM) said Friday it has submitted a new drug application to the US Food and Drug Administration for its intravenous treatment of an …

VANCOUVER (CP) - Cardiome Pharma Corp. (TSX:COM) said Friday it has submitted a new drug application to the U.S. Food and Drug Administration for its intravenous treatment of an abnormal heart rhythm.

KOLD-TV - A coalition of advertising and public relations groups is applying to the Food and Drug Administration to strip most warnings from drug ads. Their petition calls for “simpler, clearer messages” that communicate risks and benefits. The Coalition for …

A coalition of advertising and public relations groups wants to strip most of the warnings from prescription drug ads aimed at consumers.

ROCKVILLE, Md., March 31 (UPI) — The Food and Drug Administration said Friday it has approved generic Retrovir capsules to treat HIV.