FDA publishes a draft guidance recommending how to optimize and standardize dietary management in clinical trials of drugs to treat inborn errors of m...
Federal Register notice: FDA sends to OMB an information collection extension entitled Emergency Use Authorization of Medical Products and Related Aut...
CDER researchers say a five-item questionnaire they developed successfully used patient-reported data to evaluate frailty in multiple myeloma patients...
PhRMA asks the Supreme Court to reverse an 11th Circuit Appeals Court decision that held Shire could unilaterally change the Highlights section of lab...
FDA develops a policy for the use of enforcement discretion for unauthorized tests in public health emergencies.
FDA issues a complete response letter for the Xspray Pharma Dasynoc NDA, asking for additional dosing information and information on a third-party man...
Takeda withdraws a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on aspects of data collection, which cannot be ad...
