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FDA releases a guidance, S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmoni...[ Price : $8.95]
FDA revises the authorized uses and is requiring updates to product labeling regarding repeat (serial) testing for all currently a...[ Price : $8.95]
Two stakeholders comment on an FDA workshop on advancing premarket safety analytics.[ Price : $8.95]
Bristol Myers Squibb reports that its COMMANDS Phase 3 study evaluating Reblozyl (luspatercept-aamt) met its primary endpoint in f...[ Price : $8.95]
FDA recommends that health care providers discuss alternative magnetic resonance imaging-guided breast biopsy options with patient...[ Price : $8.95]
FDA alerts patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufact...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Biologics License Applications Procedu...