[ 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 refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.[ Price : $8.95]
A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit...[ 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...