FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Regeneron Urges New Guidances for Precision Medicine

[ Price : $8.95]

Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.

Glenmark Pharma Recalls Potassium Chloride

[ Price : $8.95]

Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to disso...

Biden Pressured FDA for Pfizer Covid Vaccine: House Report

[ Price : $8.95]

A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration politi...

Small Entity Compliance Guide on LDT Phase-out

[ Price : $8.95]

FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.

Endotronix Pulmonary Artery Sensor Approved

[ Price : $8.95]

FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart...

Committee Finds Troubling Foreign Inspection Issues

[ Price : $8.95]

The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspec...

FDA Denies Petition Seeking Wakix Withdrawal

[ Price : $8.95]

FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take ot...

Vyvgart Hytrulo OKd for Demyelinating Polyneuropathy

[ Price : $8.95]

FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory de...

Workshop in User Fee Meeting Management

[ Price : $8.95]

Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.

Device Consensus Standards Modifications

[ Price : $8.95]

Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes...