FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Heparin-Containing Device Labeling Guidance

[ Price : $8.95]

FDA publishes a guidance with labeling and safety testing recommendations for heparin-containing medical devices and combination p...

Janssen NDA for Urothelial Cancer Drug

[ Price : $8.95]

Janssen Pharmaceutical files an NDA seeking approval of erdafitinib for treating certain patients with locally advanced or metasta...

California Sues Abbvie Over Illegal Kickbacks

[ Price : $8.95]

California files a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (ada...

FDA Lifts, Then Dashes LASIK Patients Hopes

[ Price : $8.95]

After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH l...

Docket Number Corrected on Post-approval Changes Guide

[ Price : $8.95]

Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approva...

3 Drug Product Identifier Guidances

[ Price : $8.95]

FDA issues one draft and two final guidances explaining provisions of the Drug Supply Chain Security Act relating to drug product ...

DoJ Argues Against APA Rules Challenges

[ Price : $8.95]

Attorney Anne Walsh says the Justice Department has directed its civil litigators to oppose court attempts to impose nationwide in...

Impurity Acceptance Criteria MAPP

[ Price : $8.95]

CDER issues a Manual of Policies and Procedures on establishing drug substance and drug product impurity acceptance criteria for N...

Arca Biopharma Seeks Special Protocol for Heart Failure Trial

[ Price : $8.95]

Arca Biopharma submits a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (buci...

FDA Rejects Pharming Expanded Use for Ruconest

[ Price : $8.95]

FDA issues a Pharming Group complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to...