RAPS

FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now ...
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FDA and CMS launch RAPID pathway to speed Medicare device access

The FDA and CMS have introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway to accelerate Medicare coverage for certain FDA-designated Breakthrough Devices. By ...
RAPS

FDA Looks to Strengthen Expanded Access Program

The US Food and Drug Administration (FDA) on Thursday unveiled plans to further strengthen its expanded access program, as the controversial Right to Try legislation has yet to help any patients. The ...
JD Supra

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 ...
JD Supra

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 ...