food and drug administration

FDA to study phone number to report side effects

Tue, 25 Nov 2008 12:25:46 -0600

The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects.

FDA to open China offices after product scares

Mon, 17 Nov 2008 03:55:37 -0600

The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares.

FDA lifts Boston Scientific's product approval ban

Wed, 22 Oct 2008 10:46:46 -0500

Boston Scientific said Wednesday the Food and Drug Administration has lifted some restrictions imposed more than two years due to quality control problems.

Genentech's Raptiva receives new FDA warning

Thu, 16 Oct 2008 16:16:59 -0500

The Food and Drug Administration said Thursday it will update the labeling of Genentech Inc.'s psoriasis drug Raptiva to highlight the risk of several bacterial and viral conditions.

FDA will open inspection office in China this year

Thu, 16 Oct 2008 15:23:17 -0500

Food and Drug Administration officials say the agency will establish its first office in China before the end of the year. It's part of a broader plan to assure the safety of imports from the developing world.

Major Supreme Court cases for the new term

Sun, 05 Oct 2008 21:43:00 -0500

Highlights of some high-profile cases that the Supreme Court will take up in its term that begins Monday:

Unusual 11 Mid-Day Movers 8/27: SINT, TLB, BGP, SIFY Higher; NEX...

Wed, 27 Aug 2008 12:15:15 -0500

StreetInsider.com Unusual 11 Mid-Day Movers: NexMed, Inc. (Nasdaq: NEXM) 81.6% LOWER; announced that based on First Interpretable Results of Phase III clinical studies for NM100060, a topical application of terbinafine formulated with NexACT(R) for the treatment of onychomycosis, the decision has been taken not to submit a New Drug Application with the Food and Drug Administration at this time. Cell Genesys, Inc.

The MDS Foundation supports the FDA's decision to expand vidaza ...

Mon, 25 Aug 2008 00:00:00 -0500

(Weber Shandwick Worldwide) The Myelodysplastic Syndromes Foundation supports the decision by the US Food and Drug Administration to extend the label for vidaza to include data from the AZA-001 clinical trial. Results from the trial found that azacitidine is the only agent which has been shown to extend survival in MDS patients.

FDA approves Vidaza label expansion

Thu, 21 Aug 2008 00:00:00 -0500

(Weber Shandwick Worldwide) The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the US Food and Drug Administration has expanded the label for Vidaza (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients. Vidaza was also shown to delay progression to acute myelogenous leukemia in patients with MDS. Roughly 30 percent of patients diagnosed with MDS will progress to AML.

US FDA approves GSK's KINRIX -- new combination vaccine for chil...

Wed, 25 Jun 2008 00:00:00 -0500

(Cohn & Wolfe) GlaxoSmithKline announced today that the US Food and Drug Administration has approved KINRIX, the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.