FDA Webview

Pay Per View

Home / Pay Per View

FDA OKs SystImmune Phase 1 Lung Cancer Study

[ Price : $8.95]

FDA says SystImmune can start Phase 1 studies of its BL-B01D1 in some lung cancer patients.

FDA Actions Follow Advisors 88% of Time: Analysis

[ Price : $8.95]

Harvard Medical School researchers find FDA follows advisory committee recommendations 88% of the time, but is relying less on the...

8 Observations on Ipca Labs FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 issued following a June inspection at Indias Ipca Laboratories.

CRL for Amneal Parkinsons Drug

[ Price : $8.95]

FDA cites safety concerns in a complete response letter to Amneal Pharmaceuticals for its new formulation of Parkinsons drug carbi...

CDER Site-Selection Model MAPP

[ Price : $8.95]

CDER publishes a Manual of Policies and Procedures on the operation of its site selection process for routine inspections.

Federal Register Notices 7/3 to 7/10

[ Price : $8.95]

FDA Webview posts the Federal Register notices published during our 7/3-10 annual Independence Day break.

CDRH Moving to Electronic Export Docs

[ Price : $8.95]

CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024.

Novartis Leqvio Gets Expanded Label

[ Price : $8.95]

FDA approves a labeling update for Novartis Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an i...

29-Page Intas FDA-483

[ Price : $8.95]

FDA releases a 29-page form FDA-483 with 16 observations from a May inspection at Indias Intas Pharmaceuticals, a manufacturer of ...