FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Final Rule on Electronic Filing for Product Imports

[ Price : $8.95]

Federal Register Final Rule: FDA issues a final rule to establish requirements for the electronic filing of entries of FDA-regulat...

FDA Guidance on Drug Periodic Safety Reports

[ Price : $8.95]

FDA releases a guidance on Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evalua...

House to Vote on Cures Act This Week; Senate Vote Later

[ Price : $8.95]

The U.S. House of Representatives schedules an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in...

FDA Partially Approves Teva Petition on Generic Amrix

[ Price : $8.95]

FDA partially approves a Teva petition that sought tighter bioequivalence on generic copies of its skeletal muscle relaxant Amrix ...

Draft Guide on Submitting Quality Metrics Data

[ Price : $8.95]

FDA makes available a revised draft guidance for industry entitled Submission of Quality Metrics Data.

FDA Clears Toshiba CT Scan Reconstruction Solution

[ Price : $8.95]

FDA clears a Toshiba Medical 510(k) for the Forward Projected Model-based Iterative Reconstruction Solution that is intended to im...

Comment Period Extended on Antimicrobial Drug Use in Animals

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period on a 9/14 notice on the establishment of appropriately targeted durations ...

Pharmaceutical Science Panel to Discuss Model-informed Development

[ Price : $8.95]

Federal Register Notice: FDA announces a 3/15/2017 Pharmaceutical Science and Clinical Pharmacology Advisory Committee that will d...

Quality Metrics Data Guidance Out

[ Price : $8.95]

FDA issues a draft guidance to implement the voluntary reporting phase of its new quality metrics reporting program.

Guide on CMO Quality Agreements

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Contract Manufacturing Arrangements for Drugs: Quality Agreements...