FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Advertising Experts Critique FDAs Increasing Enforcement

[ Price : $8.95]

Pharmaceutical advertising experts react to FDAs dramatically altered enforcement approach toward prescription drug promotion sinc...

Sanofi Seeks Removal of Tzield From FDA Priority Review Program

[ Price : $8.95]

Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agencys National Priority Voucher review program following a...

Brookings Economist Backs FDA Biosimilar Draft Guide

[ Price : $8.95]

A Brookings Institution health economist voices support for FDAs revisions to a guidance on questions and answers about biosimilar...

House Committee Would Limit Foreign Trial Data

[ Price : $8.95]

Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data fro...

10 Observations in Somerset Therapeutics FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with 10 observations from a 2025 inspection at Indias Somerset Therapeutics Private Limited.

New CDER Biologics Compliance Program Explained

[ Price : $8.95]

Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspe...

Report says Makary May Face Ouster Amid White House Tensions

[ Price : $8.95]

Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of ...

Guidance On Patient-Matched Guides for Orthopedic Implants

[ Price : $8.95]

FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides u...

Expedite FDA Review of Breakthrough Mental Health Therapies: House Letter

[ Price : $8.95]

Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.

One-Day Inspection Pilot Underway at FDA

[ Price : $8.95]

FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model a...