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Panels to Discuss Ortho Evra and Blood Clot Risks

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Federal Register Notice: FDAs Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Co...

Correction Made to Withdrawal Notice

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Federal Register Notice: FDA adds an omitted footnote to a Federal Register notice that withdrew approval of 27 NDAs and 58 ANDAs.

AIDS Group Sues FDA on FOI Denials

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AIDS Healthcare Foundation sues FDA over the denial of the group's Freedom of Information Act (FOIA) requests seeking information ...

FDA OKs Medistem Stem Cell Trial for Critical Limb Ischemia

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FDA approves initiation of a Medistem Inc. clinical trial of its Endometrial Regenerative Cell adult stem cell product in patients...

ImmunoGen IND for B-cell Malignancies

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ImmunoGen files an IND for IMGN529, a potential new treatment for B-cell malignancies including non-Hodgkin's lymphoma and chronic...

FDA OKs Cross Vetpharm ANADA

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Federal Register Final rule: FDA approves a Cross Vetpharm ANADA for using tylosin tartrate in chickens, turkeys, swine, and honey...

Info on Investigational Animal Drugs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on new animal drugs for investigational uses to the Offi...

4 Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that four drug products, loxitane, zofran and dextrose injection, and fortovase, were not ...

Panels to Discuss Oral Contraceptives and Blood Clot Risks

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Federal Register Notice: FDAs Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Co...

Novartis Afinitor Phase 3 Trial Meets Primary Endpoint

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Novartis says a Phase 3 clinical study of its Afinitor tablets in patients with non-cancerous kidney tumors associated with tubero...