News & Analysis as of August 16, 2025

Manufacturers

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Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to...

Hogan Lovells on 3/3/2025

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more

Poland: impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for...

Hogan Lovells on 4/2/2019

The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques....more

The South African pharmaceutical regulatory environment

Hogan Lovells on 6/20/2018

Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more

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Medical Devices › Licensing Rules › Manufacturers

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to...

Poland: impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for...

The South African pharmaceutical regulatory environment

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