FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guidance on Tissue/Cell Therapy Deviation Reporting

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance on Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-B...

United Therapeutics Submits 4th Tyvaso Petition

[ Price : $8.95]

United Therapeutics again petitions FDA to request that the agency not approve any generic form of its Tyvaso that fails to meet c...

Genentech Recalling 3 Activase Lots

[ Price : $8.95]

FDA says Genentech is recalling three lots of Activase 100 mg vials co-packaged with Hospira sterile water in vials that may be cr...

FDA PD-1 Concerns Spread to AstraZeneca/Celgene Trials

[ Price : $8.95]

FDA concerns about PD-1/PD-L1 inhibitors spread to clinical trials for multiple myeloma, lymphoma and leukemia conducted by AstraZ...

FDA Wants Input on Regulation Review: Post

[ Price : $8.95]

FDA deputy commissioner Anna Abram says the agency is soliciting public input as it reviews all of its regulations looking for way...

CDER Researchers Looking at Protein Chemical Changes

[ Price : $8.95]

CDERs V. Ashutosh Rao describes the work Office of Biotechnology Products laboratory researchers are doing to improve the quality,...

FDA Issues for Orphan Drug Approvals

[ Price : $8.95]

FDAers discuss issues facing the agency in trying to continue its momentum in approving orphan drug designations.

EpiPen Contractor Warned on Drug CGMP, QS Violations

[ Price : $8.95]

FDAs Kansas City District Office warns Mylan EpiPen product supplier Meridian Medical Technologies about CGMP and QS violations in...

Workshop on CDER Rare Disease Drug Development

[ Price : $8.95]

Federal Register notice: FDA announces a 10/30 public workshop entitled CDER Rare Diseases Public Workshop: Strategies, Tools, and...

FDA Revamping its Industry Advice for New Technologies: Gottlieb

[ Price : $8.95]

FDA commissioner Scott Gottlieb says the agency plans to revamp its early pre-clinical involvement with medical product developers...