FDA warns Redmond, OR-based Oregons Wild Harvest about CGMP violations in its manufacturing, packaging, labeling, and holding of dietary supplements.
Several international pharmaceutical regulatory organizations, including FDA, issue a joint reflection paper on efforts toward building a pharmaceutic...
Pfizer says it will seek regulatory approval this fall for its respiratory syncytial virus prefusion F vaccine candidate.
Federal Register notice: FDA sends to OMB an information collection extension entitled Export of Medical Devices; Foreign Letters of Approval.
Writing in an online Washington Legal Foundation post, Goodwin Procter partner Matt Wetzel examines a recent appeals court decision that shot down Pfi...
FDA approves Abbotts new Precision Plus spinal cord stimulation system.
BioMarin Pharmaceutical says it will resubmit by the end of September its BLA for hemophilia A gene therapy Roctavian (valoctocogene roxaparvovec) gen...
FDA commissioner Robert Califf says there are no new questions on the recently submitted Covid-19 booster vaccines and the agency will not need an adv...
