PDUFA news from FiercePharma
NewsHow 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...
FDA mulls behind-the-counter drug sales
Once, the gap between prescription drugs and over-the-counter sales was a wide No Man's Land where few products roamed. Now, the FDA may settle more medications in this country, known as Read more...
FDA jobs won't be farmed out
Some FDA staffers can breathe a sigh of relief: Their jobs won't be farmed out to the private sector, the Read more...
Pharma, FDA to study adverse events
When it comes to predicting who'll suffer severe drug side effects, seven heads are better than one. Such is the hope of a Big Pharma consortium formed to track down genetic risk factors for serious Read more...
FDA taps new-yet-old drug chief
As the ink was still drying on the new drug-safety bill, FDA shuffled its management, bringing back Janet Woodcock as director of the Read more...
Final FDA bill lacks new DTC oversight
The Senate overwhelmingly passed the drug-safety and FDA funding bill yesterday and sent it along to President Bush for his signature. Experts are calling it a sea change in the FDA's operations. Read more...
House overhauls, passes PDUFA
Congress kicked their work on an FDA funding bill into gear--after the FDA commissioner gave them a Read more...
| Press ReleasesSTATEMENT: Pallone on FDA Revitalization Act PALLONE STATEMENT ON FDA REVITALIZATION ACT Washington, D.C. --- U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, gave the following statement Read more... PRESS RELEASE: BIO Commends House for Approving PDUFA Reauthorization Package BIO Commends House for Approving PDUFA Reauthorization Package Calls for Senate to Also Pass Legislation Before Deadline Expires WASHINGTON, D.C. (September 19, 2007) -- Biotechnology Industry Read more... |
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