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How the FDA will spend your fees

Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. The Read more...
Tags: FDA news   FDA   drug safety   FDA update   PDUFA  

A closer look at industry issues

  As we announced several weeks ago, FiercePharma will be featuring a new special section called Industry Voices. A variety of columnists will discuss issues affecting the pharmaceutical industry Read more...
Tags: Industry Voices   FDA news   FDA  

FDA's China office opens next month

FDA watchdogs will move into China next month, HHS Secretary Mike Leavitt said. The agency's Chinese office signals a new approach toward food and drug safety, he said; it's too tough to Read more...

FiercePharma passes 20K subscribers

Publisher's Note Last week the FiercePharma newsletter passed the 20,000 subscriber mark.  Thousands of more people are reading via the website and RSS feeds, and I want to thank everyone who has Read more...
Tags: Generics   FDA news   FDA  

Planning for the FDA's overhaul

Just about everybody agrees that the FDA needs a safety overhaul--including Commissioner Andrew von Eschenbach, who Read more...

Should FDA's info be in all DTC ads?

First consumers, now Congress. Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. Read more...

FDA pleas for funding gaining traction?

If there's a silver lining in the heparin cloud, it could be this: Suddenly, the FDA asking for more money to fund overseas Read more...

Agreed in committee: FDA needs money

As expected, FDA was taken to the woodshed yesterday, as experts told a Congressional Read more...
Tags: FDA news   drug safety  

Panel: Give FDA power to recall

More power to the FDA. A presidential panel is set to recommend giving the agency the authority to recall products all by its lonesome. It would be a sea change; now, the FDA can only pressure Read more...
Tags: FDA   FDA news   FDA recalls  

Press Releases

PRESS RELEASE: Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry Connection of genetic information with medication use can improve safe use of product Read more...

PRESS RELEASE: FDA Advisors Declare 'FDA Science and Mission at Risk'

FDA Advisors Declare 'FDA Science and Mission at Risk' Broad-ranging Report Concludes that Increased Resources Are An Essential First Step WASHINGTON, Dec. 3 -- The nation's food supply is at risk, Read more...

PRESS RELEASE: FDA Announces Steps to Improve Advisory Committee Processes

FDA Announces Steps to Improve Advisory Committee Processes The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with Read more...

SPEECH: President Bush Discusses Import Safety

President Bush Discusses Import Safety  THE PRESIDENT: Thank you all. Good afternoon. I just had an important briefing from Secretary Leavitt and other members of the inter-agency working group on Read more...

PRESS RELEASE: Fact Sheet: Import Safety Action Plan: Increasing Protection of American Consumers

Fact Sheet: Import Safety Action Plan: Increasing Protection of American Consumers Interagency Working Group On Import Safety Presents Action Plan To President Bush Today, the Interagency Working Read more...

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