Five stakeholders recommend changes to an FDA draft guidance on good ANDA submissions.
Federal Register notice: FDA classifies the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls).
FDA commissioner Scott Gottlieb says he wants more agency investigators at international mail facilities to help intercept illegal drug shipments, par...
Federal Register notice: FDA seeks comments on an information collection for Reclassification Petitions for Medical Devices 21 CFR Section 860.123 (O...
Sagent Pharmaceuticals recalls 10 lots of methylprednisolone sodium succinate for injection (40mg, 125mg and 1g) due to the discovery of high out-of-s...
Dermiras investigational treatment olumacostat glasaretil fails to meet its co-primary endpoints in two Phase 3 pivotal trials in patients ages nine y...
FDA warns Hong Kongs Nan San Pharmaceutical Company about CGMP and other violations in its production of finished pharmaceuticals.
FDA releases its latest batch of Warning Letters that includes Nan San (HK) Pharmaceutical Factory and Zhejiang Ludao Technology Co.