FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Draft Guide on CLIA Waivers

[ Price : $8.95]

FDA posts a draft guidance on Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Wai...

FDA Adds Patent Submission Dates to Orange Book

[ Price : $8.95]

Two Hyman, Phelps attorneys say FDA is helping generic drug applicants by starting to list patent submission dates in the Orange B...

FDA Guide on Pediatric Info in X-ray 510(k)s

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Pediatric Information for X-ray Imaging Device Premarket Notifica...

FDA Reducing Hurdles for Generic Complex Drugs: Gottlieb

[ Price : $8.95]

Commissioner Scott Gottlieb says FDA ramps up its efforts to improve the process for developing generic copies of complex drugs.

Safety Alert on Biotin Affecting Lab Testing

[ Price : $8.95]

An FDA safety alert warns that dietary supplements containing biotin (vitamin B7) can cause clinically significant incorrect lab t...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes Dae Young Foods Co. and JMA Partners, Inc.

Biologics Companies Cutting Production Costs: White Paper

[ Price : $8.95]

A Tufts Center for the Study of Drug Development roundtable discussion finds that innovative biologics manufacturing is cutting co...

FDA Info Collection Extension for eRecords

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Electronic Records; Electronic Signatures O...

Regeneron Not Moving Eye Drug Combo Into Phase 3

[ Price : $8.95]

Regeneron Pharmaceuticals says two Phase 2 studies looking at adding investigational drug nesvacumab to the companys already-appro...

Comments Sought on Export Certificates Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Export of FDA-Regulated Products: Export Ce...