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Info on Xenotransplantation Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on infectious disease issues in xenotransplantation to the...

Public Meeting on REMS for Opioid Drug Products

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Federal Register Notice: FDA plans a public meeting 12/4 to discuss Risk Evaluation and Mitigation Strategies for certain opioid d...

Info on User Fee Cover Sheet Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on the user fee cover sheet to the Office of Management an...

Number Changed for Anti-Infective Drugs Meeting

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Federal Register Notice: FDA amends a notice of a 12/9 meeting of the Anti-Infective Drugs Advisory Committee to change the hotel ...

FDA, Waterfront Media Sign MOU

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Federal Register Notice: FDA provides notice of a memorandum of understanding between FDA and Waterfront Media to provide better i...

FDA Still Reviewing Hyperthermia System

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FDA asks BSD Medical Corp. additional questions on its HDE for the BSD-2000 Hyperthermia System.

It's Unlikely Adjuvants will be Used in H1N1 Vaccine: Goodman

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FDA chief scientist Jesse Goodman tells Congress that adjuvant use with the H1N1 vaccine would only occur if it were determined th...

Grassley Questions Med Schools About Drug Company Money

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Sen. Chuck Grassley asks nine medical schools for information on their policies and actions involving ghostwriting medical article...

FDA Warns Medtronic Facility

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FDA warns Medtronic on four areas of deficiencies at its Mounds View, MN, manufacturing facility.

FDA Meets with StemCells, Inc. on Development Plans

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FDA tells StemCells, Inc., that safety data on its HuCNS-SC neural stem cells warrant continued clinical development to treat Batt...