Three stakeholders comment on an FDA draft guidance on rescinding breakthrough therapy designations.
FDA approves a Pharmacyclics supplemental NDA for Imbruvica (ibrutinib) for certain pediatric patients over one year of age with chronic graft versus ...
FDA publishes drug safety-related labeling changes for Gleevec and Rapamune.
A House Select Subcommittee on the Coronavirus Crisis report details evidence of what it sees as inappropriate Trump administration pressure on FDA ov...
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR part 814...
Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Device Labeling Regulations.
Two Mintz attorneys discuss questions raised by a recent FDA Warning Letter involving the Amazon.com fulfillment service that delivered unapproved dru...
The Informed Consent Action Network says FDA should withdraw approval of the IPOL polio vaccine until adequate clinical trials demonstrate its safety.
