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TherapeuticsMD says it will submit additional endometrial safety information to address the only approvability issue raised in May...[ Price : $8.95]
FDA posts a guide for physicians seeking to submit requests for non-emergency single-patient expanded access to investigational th...[ Price : $8.95]
Federal Register notice: FDA announces the availability of a guidance on Qualification of Medical Device Development Tools (MDDT) ...[ Price : $8.95]
CDRH answers frequently asked questions about its new medical device pre-certification program.[ Price : $8.95]
United Therapeutics sues FDA to get orphan drug exclusivity for its Orenitram extended-release tablets for treating pulmonary arte...[ Price : $8.95]
FDA issues a safety alert update based on receiving five reports of unanticipated deaths since 2016 in patients with liquid-filled...[ Price : $8.95]
FDA issues a safety alert on sterile drug products that are produced and distributed nationwide by Vital Rx Inc. (dba Atlantic Pha...[ Price : $8.95]
Federal Register notice: FDA announces a 9/8 Medical Imaging Drugs Advisory Committee meeting.