On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Regulatory Considerations for Prescription Drug Use-Related Software”. This guidance describes how FDA intends to apply its drug-labeling authority to certain software outputs for use with a prescription drug or a prescription drug-led, drug-device combination product. In this guidance, prescription drug use related software generally includes software that (1) is disseminated by or on behalf of a drug sponsor and (2) produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products. FDA considers end-user output a type of prescription drug labeling. AMCP submitted comments in response to this guidance on December 18, 2023.
AMCP's most recent Partnership Forum drew participants from a range of backgrounds and perspectives to discuss the value of collaboration between health plans/payers and patient advocacy organizations in managed care pharmacy decision-making. Senior VP of Professional and Government Affairs Jennifer Mathieu shares key insights and takeaways from the event.
By Jennifer L. Mathieu, Senior Vice President, Professional and Government Affairs, AMCP • 12/15/23
Alopecia areata is a disease that happens when the immune system attacks hair follicles and causes hair loss. While hair can be lost from any part of the body, alopecia areata usually affects the head and face.
This sponsored webinar explores the unique product characteristics of different botulinum toxin type A (BoNT/A) products and the clinical implications of these differences.
As part of AMCP Foundation's efforts to train managed care pharmacists in specialized care practices, Raquel Erb, a PharmD candidate at the University of Texas at Austin, College of Pharmacy, completed our inaugural internship sponsored by Sanofi, studying and optimizing the benefit design of specialty drugs.
This sponsored webinar provides an overview of the patient journey to treatment and discusses signs and diagnosis of early Alzheimer's Disease, the clinical trial data in informing selection for treatment for appropriate patients, key considerations for initiating the treatment, and monitoring for safety.
JMCP’s Editor-in-Chief shares three reasons to check out JMCP’s new website, including the Managed Care Pharmacy Primer Series, timely papers on implementation of the IRA, and JMCP’s policy on AI.
By Laura E. Happe, PharmD, MPH, Editor-in-Chief, JMCP • 12/6/23