FDA moves to enhance drug safety.(US Food and Drug Administration)

Chain Drug Review;  February 19, 2007 ;     700+ words ......to improve drug safety and expand...office of drug safety, which monitors...rather than postmarket surveillance. But agency...regard to drug safety, he says...expanding postmarket drug safety initiatives...

User Fees, Drug Safety

Pharmaceutical Technology;  February 1, 2006 ;     700+ words ......weighs changes for drug safety initiatives and expanded...more fee revenues to drug-safety surveillance, an area...discovery through postmarket surveillance. The added resources...expand postapproval drug safety surveillance, boost...to establish new drug ...

FDA Establishes Drug Safety Panel

Pharmaceutical Executive;  March 1, 2005 ;     292 words ...SAFETY Critics argue that the new Drug Safety Oversight Board is not capable of handling...administration will leave oversight of drug safety with the FDA. Some members of Congress...independence." One, the aforementioned Drug Safety Oversight Board, will examine drug ...

PRESCRIPTION DRUG SAFETY:BRUCE M. PSATY

Congressional Testimony;  March 3, 2005 ;     700+ words ......broad interests in public health and drug safety. The COX-2 inhibitors, a new class of...Indeed, the integrity of the American drug-safety system itself has been questioned. How...3. Create an independent Center for Drug Safety within the FDA to oversee drugs after...

Monitoring drug safety

The Milwaukee Journal Sentinel;  November 30, 2004 ;     467 words ...Monitoring drug safety The public should have reasonable...injury. The editors said that this drug safety board should be independent of the...whether it was adequately tracking drug safety. Let us suggest that the jury is already...

IoM drug safety study may buy time for FDA; report will play in PDUFA...

Pharmaceutical Processing;  December 1, 2004 ;     265 words ......with an Institute of Medicine review of drug safety regulation could trigger a full-fledged...creating a separate entity to oversee drug safety issues, Center for Drug Evaluation...at this question of organization of drug safety, Galson said. The idea of an independent...

Drug Safety: Where to Start?

Applied Clinical Trials;  February 1, 2008 ;     552 words ......to the industry's perceived current drug safety problem. But starting with just one...emerged: safety. More specifically, how drug safety could be clarified through better information...approvals driven by the current force of drug safety. As Paul notes: "We are currently in...

REPS. WAXMAN, MARKEY INTRODUCE COUNTERPART TO ENZI-KENNEDY DRUG SAFETY...

US Fed News Service, Including US State News;  March 20, 2007 ;     581 words ......House counterpart to the Enzi-Kennedy Enhancing Drug Safety and Innovation Act of 2007 (S. 484). H.R. 1561 builds on the Senate drug safety bill to further increase FDA's post-market drug safety authority, provide greater FDA transparency, and...

FDA seeks input on communication of drug safety information; Public...

M2 Presswire;  December 7, 2005 ;     700+ words ......FDA seeks input on communication of drug safety information; Public meeting brings together...devise a modern system for communicating drug safety information to educate healthcare providers...across the organization are dedicated to drug safety. To date, there are a number of ...

FDA plans reorganization to improve drug safety.(Rx)

Internal Medicine News;  January 1, 2006 ;     598 words ......to improve the agency's approach to drug safety and to help improve drug development...and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency...officials also plan to consolidate some drug safety--related activities and have that staff...

FDA Publishes Guidance on Communication of Drug Safety Information.

M2 Presswire;  March 5, 2007 ;     700+ words ......Publishes Guidance on Communication of Drug Safety Information(C)1994-2007 M2 COMMUNICATIONS...s current approach to communicating drug safety information, including emerging safety...information is communicated. Important drug safety information has the potential to alter...

FDA plans reorganization aimed at improving drug safety, development.(Food...

Clinical Psychiatry News;  January 1, 2006 ;     532 words ......to improve the agency's approach to drug safety and to help improve drug development...and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency...officials also plan to consolidate some drug safety-related activities and have that staff...

FDA reorganizing to improve drug safety, development.(Practice Trends)

OB GYN News;  January 15, 2006 ;     552 words ......to improve the agency's approach to drug safety and to help improve drug development...and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency...officials also plan to consolidate some drug safety-related activities and have that staff...

FDA PUBLISHES GUIDANCE ON COMMUNICATION OF DRUG SAFETY INFORMATION

US Fed News Service, Including US State News;  March 2, 2007 ;     700+ words ......s current approach to communicating drug safety information, including emerging safety...information is communicated. Important drug safety information has the potential to alter...ency's commitment to communicate important drug safety information in a timely manner, including...

FDA restructuring aims to address drug safety.(Practice Trends)

Skin & Allergy News;  January 1, 2006 ;     599 words ......to improve the agency's approach to drug safety and to help improve drug development...and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency...officials also plan to consolidate some drug safety-related activities and have that staff...