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Panel to Discuss Melanoma and Thyroid Cancer Treatments

[ Price : $8.95]

Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/2 to discuss Bristol-Myers Squibbs BLA for advanced ...

Public Workshop on Treating Severe Bleeding

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 12/9-10 on product development programs for patients with severe bleeding due...

FDA Schedules Product Development Workshop

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FDA announces a two-day public workshop on products to intervene in patients with severe bleeding.

FDA 'Fast Track' for Urea Cycle Therapy

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FDA grants Hyperion Therapeutics a fast track designation for HPN-100 (glycerol phenylbutyrate) and its use as an adjunctive thera...

ReGen Sees FDA Politics, False Allegations

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ReGen says FDA politics and false allegations are behind the decision to rescind 510(k) clearance for its Menaflex knee implant.

FDA Panel Backs Continued Use of ESAs in Kidney Disease Patients

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An FDA advisory committee 10/18 votes 15 to 1 that erythropoiesis stimulating agents can continue to be used in kidney disease pat...

Info on Device QSRs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on quality system regulations for medical devices to the...

Info on Medically Necessary Products Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information, a draft guidance on ensuring medically necessary products...

FDA OKs Bristol-Myers sNDA for Chronic Hepatitis B with Liver Disease

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FDA approves a Bristol-Myers Squibb supplemental NDA for Baraclude for treating chronic hepatitis B in adults with decompensated l...

FDA Puts New Rules on Generic AndroGel Applicants

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CDER grants some Abbott requests relating to applications for generic AndroGel but rejects other company requests.