Physician's Weekly
JUNE 18, 2025
Cost-sharing and education may improve access to GLP-1 therapies for obesity, but systemic barriers remain, requiring broader policy and clinical reforms. Other Persistent Barriers & Potential Solutions In another article not presented at the meeting, Stephanie W. They published their insights in Nature Medicine.
FDA Law Blog
MARCH 19, 2024
is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers.
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FDA Law Blog
JUNE 24, 2024
HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. Since its inception, the Format has been instrumental in standardizing the submission process, ensuring that critical data is presented in a clear and consistent manner.
FDA Law Blog
JANUARY 18, 2022
This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”
FDA Law Blog
JANUARY 18, 2022
This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”
FDA Law Blog
AUGUST 23, 2021
Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. By McKenzie E. Cato & Alan M. not friends, significant others, or family members of a speaker or invitee).
FDA Law Blog
SEPTEMBER 22, 2024
MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).
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