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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinic 64
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‘We Need To Keep Fighting’: HIV Activists Organize To Save Lives as Trump Guts Funding

Physician's Weekly

In the 1980s, the government refused to acknowledge HIV as gay men died young. Scientists had developed powerful HIV drugs that, if taken daily, transform it from a death sentence into a manageable chronic disease in which a person’s virus levels are so suppressed that they cannot spread HIV to others.