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FDA Could Have Done Better for Staff Training at OPM

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Consulting editor John Scharmann compares expensive outsourced FDA staff training programs with low-cost comparable programs at th...

Animal Drug Sponsor Changed to Belcher Pharmaceuticals

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Federal Register Final rule: FDA changes an animal drug sponsor name in the regulations to Belcher Pharmaceuticals LLC.

Comments Sought on Type A Medicated Articles

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Federal Register Notice: FDA seeks comments on recordkeeping requirements for Type A medicated article manufacturers.

List of Approved PMAs Published

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Federal Register Notice: FDA publishes a list of approved PMAs to inform the public of the availability of safety and effectivenes...

Blood Products Panel to Meet

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Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/14-15 to discuss dengue virus infection, murine leuke...

Comments Sought on Animal Drug User Fee Form

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Federal Register Notice: FDA seeks comments on the Animal Drug User Fee Act Cover Sheet.

Comments Sought on Medicated Feed CGMP

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Federal Register Notice: FDA seeks comments on CGMPs for medicated feeds.

FDA Seeks Information on Sedation Products

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Federal Register Notice: FDA seeks information and encourages a public meeting to discuss issues on the clinical development and u...

Guidance on IVDs to Detect C. Difficile

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Federal Register Notice: FDA releases a draft guidance on establishing the performance characteristics of IVDs for detecting C. di...

Guidance on Drugs to Treat Pneumonia

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Federal Register Notice: FDA releases a draft guidance on developing drugs to treat hospital-acquired bacterial pneumonia and vent...