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A review of FDA inspection documents by the journal Science on the agencys clinical trial oversight during the past 11 years shows...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impur...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter With...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on Breast Implants Certain Labeling Recommendations to Improve Pati...[ Price : $8.95]
Seven former FDA commissioners call on the White House to let FDA do its scientific work without political interference.[ Price : $8.95]
FDA updates the SARS-CoV-2 reference panel comparative data.[ Price : $8.95]
FDA issues a draft guidance on using PBPK analyses for some biopharmaceutics applications.[ Price : $8.95]
Catalyst says it will appeal a Florida federal court ruling dismissing its case against FDA over orphan drug exclusivity for Firda...