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FDA releases an updated guidance document that provides recommendations on the chemistry, manufacturing, and controls information ...[ Price : $8.95]
An FDA inspection finds continuing and repeat quality violations at a McNeil Puerto Rico manufacturing facility.[ Price : $8.95]
FDA issues two guidances on aspects of antibacterial drugs.[ Price : $8.95]
Consulting editor John Scharmann compares expensive outsourced FDA staff training programs with low-cost comparable programs at th...[ Price : $8.95]
Federal Register Final rule: FDA changes an animal drug sponsor name in the regulations to Belcher Pharmaceuticals LLC.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on recordkeeping requirements for Type A medicated article manufacturers.[ Price : $8.95]
Federal Register Notice: FDA publishes a list of approved PMAs to inform the public of the availability of safety and effectivenes...[ Price : $8.95]
Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/14-15 to discuss dengue virus infection, murine leuke...