FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Boston Scientific Positive Ablation Study

[ Price : $8.95]

Boston Scientific reports positive 12-month results from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation ...

Data Integrity Issues at Synapse Labs: Petition

[ Price : $8.95]

A Flag Pharma citizen petition asks FDA to revisit the therapeutic equivalence ratings of generic drug products that relied on bio...

FDA Clears BioProtect Balloon Implant

[ Price : $8.95]

FDA clears a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection ...

AbbVie sBLA for Skyrizi in Crohns

[ Price : $8.95]

AbbVie submits a supplemental BLA for Skyrizi (risankizumab) 1,200 mg intravenous (induction dose) and 180 mg and 360 mg subcutane...

Novocure Phase 3 Study Misses Primary Endpoint

[ Price : $8.95]

Novocure says its Phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 clinical trial of Tumor Treating Fields together with paclitaxel in patie...

Final Guide on Product Tracing Enforcement

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security Requirements Under Sect...

Enforcement Deferred on Drug Security Needs

[ Price : $8.95]

FDA posts a guidance on new enforcement deferments affecting enhanced drug distribution security requirements.

Inmar Recalls Products Due to Rodent Infestation

[ Price : $8.95]

Inmar Supply Chain Solutions recalls FDA-regulated products (over-the-counter (OTC) human or animal drugs, OTC medical devices, di...

Comments Sought on Pepaxtos Proposed Withdrawal

[ Price : $8.95]

CDER asks for comments on its proposal to withdraw Oncopeptides accelerated-approved multiple myeloma drug Pepaxto (melphalan fluf...

CDRH Qualifies Tool on Material Biostability

[ Price : $8.95]

CDRH announces the qualification of a new tool through the agencys voluntary Medical Device Development Tools program: Accelerated...