FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Arthritis Advisory Committee Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA renews its Arthritis Advisory Committee for an additional two years.

Final Guide on 510(k) Template for eSubmission

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device 510(k) Su...

Expand RTOR to Cell, Tissue Products: PhRMA

[ Price : $8.95]

PhRMA says the FDA Oncology Center of Excellence Real-Time Oncology Review (RTOR) program should be expanded to include tissue and...

Comments on Therapeutic Equivalence Draft Guidance

[ Price : $8.95]

Five stakeholders comment on an FDA draft guidance on therapeutic equivalence evaluations.

OPDP to Study TV Ad Endorsers

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion says it wants to expand a current study on endorsers in print and Internet ads to c...

2 Prescription Drug Promotion Studies Proposed

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion proposes to study consumer and healthcare provider perceptions about drugs that com...

FDA Approves Medtronic Indication for Onyx Stents

[ Price : $8.95]

FDA approves two Medtronic drug-eluting stents for use in treating non-left main bifurcation lesions in the heart.

FDA Clears AI Colon Polyp Detector

[ Price : $8.95]

FDA clears an Iterative Scopes 510(k) for SKOUT, a computer-aided polyp detection device for adults undergoing colorectal cancer s...

User Fee Reauthorization Agreement Reached in Senate

[ Price : $8.95]

Senate Health, Education, Labor and Pensions Committee leaders reach agreement to reauthorize FDAs user fee programs for an additi...

Lillys Retevmo Gains Regular FDA Approval

[ Price : $8.95]

FDA grants regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating certain adul...