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Let It Grow: FDA Revises Q&A Guidance to Support Sponsors With the Implementation of Expanded Access Programs

“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational ...
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BioCorRx Submits Expanded Access Treatment Protocol to FDA for BICX104, Implantable Biodegradable Naltrexone Pellet for Treatment of Opioid Use Disorder

Company Hopes in 30 Days to Begin Making Its Drug Candidate Available to Help Patients and Address Public Health Crisis Brady Granier, President of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, ...
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FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
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NKGen Receives FDA Expanded Access Protocol Authorization for Landmark Treatment of Several Neurodegenerative Diseases

Troculeucel, a cryopreserved, autologous enhanced natural killer cell therapy, has demonstrated preliminary clinical benefit without any drug-related adverse events in two Phase I clinical trials in ...