FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Provention Bio Diabetes Delayer Approved

[ Price : $8.95]

FDA approves a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes ...

Inspections Focusing on Management Responsibility: FDA

[ Price : $8.95]

FDA Office of Regulatory Affairs Division of Pharmaceutical Quality Operations III program director Jeffrey Meng tells an industry...

Pfizer/BioNTech on Encouraging Covid Booster Data

[ Price : $8.95]

Pfizer and BioNTech announce results showing that their current authorized bivalent booster vaccine provides a greater increase in...

Iovance Pushes Back BLA for Melanoma Therapy

[ Price : $8.95]

Iovance Biotherapeutics delays its completion of a rolling BLA submission for lifileucel, an investigational tumor infiltrating ly...

Animal Drug User Fees Reauthorization Meeting

[ Price : $8.95]

Federal Register notice: FDA announces a 12/7 public meeting entitled Animal Drug User Fee Act to discuss reauthorizing the user f...

Bernie Sanders to Head HELP Committee

[ Price : $8.95]

Senator Bernie Sanders (I-VT) looks to become chairman of the Health, Education, Labor and Pensions (HELP) Committee after current...

Guidance on Compounding Amoxicillin Due to Shortages

[ Price : $8.95]

FDA issues an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by p...

FDA Withdraws 10 No-Longer-Marketed ANDAs

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they told the agency the products were ...

Philips Respironics Reports More Problems with Ventilators

[ Price : $8.95]

FDA asks for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of ...

More Draft ANDA Bioequivalence Guides Available

[ Price : $8.95]

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for use by ANDA sponsor...