Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and related symptoms.
FDA publishes a draft guidance on the Advanced Manufacturing Technologies Designation Program and its benefits for drug development.
Utah-based medical device company Dolor Technologies settles False Claims Act charges with the federal government over a device it sold for treating m...
FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.
CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating drug-drug interaction...
Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Stud...
Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests without adequate resour...
More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (optimal dose) informa...
