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FDA says it is creating a nine-member Genetic Metabolic Diseases Advisory Committee.[ Price : $8.95]
Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and relate...[ Price : $8.95]
FDA publishes a draft guidance on the Advanced Manufacturing Technologies Designation Program and its benefits for drug developmen...[ Price : $8.95]
Utah-based medical device company Dolor Technologies settles False Claims Act charges with the federal government over a device it...[ Price : $8.95]
FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.[ Price : $8.95]
CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating d...[ Price : $8.95]
Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Con...[ Price : $8.95]
Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests wit...