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Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a st...[ Price : $8.95]
FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.[ Price : $8.95]
Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2...[ Price : $8.95]
Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.[ Price : $8.95]
FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutica...[ Price : $8.95]
FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its find...[ Price : $8.95]
A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.