FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Groups Urge Congress to Advance Generic Drug Bills

[ Price : $8.95]

Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowerin...

FDA Grants Outlook Therapeutics Dispute Resolution Request

[ Price : $8.95]

FDA agrees to hear an Outlook Therapeutics formal dispute resolution request regarding the agencys prior rejection of eye disease ...

Federal Judge Pauses Challenge to Abortion Pill Rules

[ Price : $8.95]

A federal judge declines to immediately restrict access to the abortion pill mifepristone, instead pausing a high-profile lawsuit ...

Support for Rare Disease Education Materials

[ Price : $8.95]

Three stakeholders express support for FDAs LEADER 3D rare disease educational materials and suggest ways to improve them.

Positive Phase 3 Date for Subcutaneous Tepezza: Amgen

[ Price : $8.95]

Amgen reports positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepe...

ImmunityBio Responds to FDA Concerns Over Promotional Materials

[ Price : $8.95]

ImmunityBio says it has responded to FDAs recent Warning Letter on the companys alleged misleading promotional claims about its ca...

Anumana Pulmonary Hypertension AI Tool Wins Clearance

[ Price : $8.95]

FDA clears an Anumana 510(k) for an artificial intelligencebased tool designed to detect early signs of pulmonary hypertension.

FDA Flags Quality System Gaps at CSL Behring Site

[ Price : $8.95]

FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring...

FDA 483 Guidance Raises Compliance Bar: Cooley

[ Price : $8.95]

FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following in...

FDA Budget Request Seeks 3% Increase

[ Price : $8.95]

FDAs just-released proposed fiscal year 2027 budget seeks a 3.3% increase or about $200 million to fund the agencys operations.