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Expediting parallel drug approval pathways is challenging, but rewarding

Global agencies have collaborated to create parallel regulatory approval solutions to help get drugs to patients more quickly. Experts who have used these schemes say that while these schemes have ...

FDA proposes new treatment approval pathway for ultrarare diseases

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
News Medical

The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
JD Supra

FDA Announces “plausible Mechanism” Approval Pathway for Certain Personalized Therapies, With Few Details

Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England ...
JD Supra

Biological Products Regulation Part 2: What Is the Regulatory Pathway for Biological Products?

In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...