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News

Feds steering funds back to basic AIDS vax research

After trying and failing repeatedly to develop an AIDS vaccine, federal officials say they're going back to the drawing board to come up with some new ideas. Read more...

Hawaii Biotech moves West Nile vaccine into clinic

Hawaii Biotech has passed a key milestone in its development, winning approval to begin a small human trial of its experimental vaccine to combat West Nile disease. Hawaii Biotech says that the FDA Read more...

Press Releases

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...

PRESS RELEASE: FDA Sends Sanofi Warning Letter for Ketek Study

FDA Sends Sanofi Warning Letter for Ketek Study ROCKVILLE, Md., Oct. 24, 2007--The FDA posted on its web site a letter to Sanofi-aventis regarding a study with the antibiotic Ketek. DEPARTMENT OF Read more...

PRESS RELEASE: OIG Releases Report of FDA’s Oversight of Clinical Trials

OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed WASHINGTON, Sept. 28, 2007—Weaknesses in the Food and Drug Read more...

PRESS RELEASE: FDA Clears Genetic Lab Test for Warfarin Sensitivity

FDA Clears Genetic Lab Test for Warfarin Sensitivity The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be Read more...

PRESS RELEASE: Cephalon Warns Doctors Over Pain Drug Deaths Says FDA

Cephalon Warns Doctors Over Pain Drug Deaths Says FDA FRAZER, Pa., Sept. 13 -- Cephalon, Inc. today communicated with healthcare professionals to clarify the appropriate patient selection, dosing Read more...