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FDA Budget Request Seeks 3% Increase

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

FDA Patient Preference Guide Addresses 510(k) Applicability

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FDAs updated guidance on how patient preference information can be incorporated into regulatory decision-making for medical device...

Positive Phase 3 Date for Subcutaneous Tepezza: Amgen

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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

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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

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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

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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

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FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following in...

FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments

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FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see t...

October Deadline for New Adverse Event Reporting Standard

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FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for ...

Context Therapeutics Ovarian Cancer Drug Wins Fast Track

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FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovar...