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FDA Might Lack Balance Between Speed, Safety In Prescription Drug Reviews
Several recent problems with prescription drug safety has "led many on Capitol Hill to question" whether FDA has "failed to strike the right balance b...

FDA Grants Priority Review for Oral Formulation of HYCAMTIN (topotecan) to Treat Relapsed Small Cell Lung Cancer
GlaxoSmithKline (GSK) announced that its new drug application (NDA) for ORAL HYCAMTIN (topotecan) capsules, a treatment for relapsed small cell lung c...

FDA Releases Human Tissue Task Force Report
The U.S. Food and Drug Administration (FDA) released a report that concludes there are no significant industrywide problems in the recovery of human t...

FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer
ImClone Systems and Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, a sup...

FDA Announces New Advisory Committee to Address Risk Communication
The U.S. Food and Drug Administration (FDA) announced a new advisory committee designed to counsel the agency on how to strengthen the communication o...

FDA Science Board to Meet on June 14
The U.S. Food and Drug Administration’s (FDA) Science Board will hold a public meeting on June 14, 2007. The board, an advisory committee to the FDA, ...

FDALive.com to Broadcast the June 13th FDA Hearing on Zimulti
Video On Location Inc. (VOLi), the parent company to FDALive.com, is the world's leading source for FDA meeting broadcasting. FDALive.com broadcasts m...

Pro-Pharmaceuticals Submits Data to Begin a 505 Filing with the FDA for a New Formulation of Irinotecan
Pro-Pharmaceuticals, a Company “Advancing Drugs Through Glycoscience”, today announced it has submitted data to begin a filing under Section 505 (b)(2...

Aspreva Announces Fast-Track Designation Granted By The FDA For CellCept In Lupus Nephritis
Aspreva Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CellCept (mycoph...

FDA Announces New Advisory Committee To Address Risk Communication
The U.S. Food and Drug Administration (FDA) announced a new advisory committee designed to counsel the agency on how to strengthen the communication o...

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