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Human Drugs

Comments on Good ANDA Submission Practices

Five stakeholders recommend changes to an FDA draft guidance on good ANDA submissions.

Federal Register

Class 2 for Extracorporeal Shock Wave Device

Federal Register notice: FDA classifies the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls).

Human Drugs

Gottlieb Wants More FDA Staff at International Mail Facilities

FDA commissioner Scott Gottlieb says he wants more agency investigators at international mail facilities to help intercept illegal drug shipments, par...

Federal Register

Comments Sought on Device Reclassification Info Collection

Federal Register notice: FDA seeks comments on an information collection for Reclassification Petitions for Medical Devices 21 CFR Section 860.123 (O...

Human Drugs

Sagent Recalls 10 Lots of Methylprednisolone

Sagent Pharmaceuticals recalls 10 lots of methylprednisolone sodium succinate for injection (40mg, 125mg and 1g) due to the discovery of high out-of-s...

Human Drugs

Dermira Acne Drug Misses Endpoints in Phase 3

Dermiras investigational treatment olumacostat glasaretil fails to meet its co-primary endpoints in two Phase 3 pivotal trials in patients ages nine y...

Human Drugs

Multiple Violations at Nan San Pharmaceutical

FDA warns Hong Kongs Nan San Pharmaceutical Company about CGMP and other violations in its production of finished pharmaceuticals.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Nan San (HK) Pharmaceutical Factory and Zhejiang Ludao Technology Co.

Medical Devices

Expanded Approval for St. Jude Medical Heart Valve

FDA expands the approval of St. Jude Medicals Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include a 15-mm valve size t...

Human Drugs

Sen. Smith Introduces Pay-for-Delay Bill

Sen. Tina Smith introduces legislation to enable FDA to withdraw a generic drugs 180-days of exclusivity if it enters into a pay-for-delay agreement w...