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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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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AAP Updates Recommendations for Adolescent Contraceptive Counseling

Physician's Weekly

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. ” Abstract/Full Text Copyright © 2025 HealthDay.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

Naheed 15:56 2014. Eric 15:57 2014. I’m guessing, like here, especially in 2014, almost none of it was. They’re more, more interested in relationship centered care than the fancy medicines that you’re. And I wonder if that is key in patients, people who are experiencing homelessness as well.

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. And that’s a good thing to share with an older patient or client that making decisions about your activity.