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A May FDA inspection of Thoratecs Pleasanton, CA medical device manufacturing facility finds issues with the company design valida...[ Price : $8.95]
FDA publishes a draft guidance on studies for establishing performance characteristics of highly multiplexed microbiological/medic...[ Price : $8.95]
A Massachusetts federal court dismisses a Takeda whistleblower case alleging the company failed to report adverse events involving...[ Price : $8.95]
Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/4-5 to discuss labeling of red blood cells and infect...[ Price : $8.95]
Hospira CEO Michael Ball says FDA recently intensified its inspections of the troubled medical product maker.[ Price : $8.95]
In contrast to company comments, AdvaMed asks FDA to make changes to its proposed unique device identification system to make the ...[ Price : $8.95]
Merck submits a standard review NDA for suvorexant, a controlled substance drug indicated for treating insomnia.[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says a Curosurf pitch letter and news release omit important risk information and incl...