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Doctor Failed to Follow Investigational Plan: FDA

[ Price : $8.95]

FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.

Workshop on Improving Pregnancy Drug Safety Registries

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FDA plans a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the saf...

Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

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Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis ...

Support for Rare Disease Education Materials

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

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...