FDA news news from FierceBiotech
NewsEschenbach offers 'Andy's Take' on FDA issues
Eschenbach offers 'Andy's Take' on FDA issues The ever-growing blogosphere has a new voice--none other than FDA commissioner Andrew von Eschenbach. At Read more...
Canadian regulators forging new biosimilar pathway
While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Read more...
FDA designation turns into fast track to nowhere
Life in the biotech fast lane is good for investors, not so great for patients--or so says the Cleveland Plain Dealer after a seven-month investigation of the FDA's record on fast-track drugs. Read more...
EU, U.S. regulators offer single orphan drug path
Regulators in Europe and the U.S. have joined together to create a common application form for developers seeking orphan drug status. By making it easier to file the regulators are hoping that they Read more...
New drug approval lags in 2007
The FDA has suffered no small amount of criticism recently, and, according to the Wall Street Journal, the agency's efforts to protect itself from naysayers have contributed significantly to he low Read more...
FDA, Big Pharma team up on drug research center
In all the hoopla over the new FDA funding-and-reform legislation last month, a key provision was Read more...
Report: FDA lax in clinical trial oversight
A new report has found that the FDA does little to protect the safety of patients who participate in clinical trials. Daniel R. Levinson, inspector general of the Department of Health and Human Read more...
FDA, Big Pharma collaborate on genetic tests
Seven of the world's biggest drug makers are banding together to create a research consortium that will develop genetic tests that can identify patients vulnerable to dangerous adverse events. Under Read more...
House passes PDUFA: bill heads to Senate
The U.S. House of Representatives has passed a bill to renew the Prescription Drug User Fee Act (PDUFA), positioning it to be passed by the Senate and signed by the President before the Friday Read more...
| Press ReleasesPRESS 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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