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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more
The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more
Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more
118th Congress Continues to Grapple with Contentious CR. With the collapse of Republican support for the negotiated continuing resolution (CR) package, as of the time of publication on Friday at 3:00 PM EST, Congress is still...more
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more
Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...more
In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...more
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more
On August 20, 2015, the Colorado Medical Board (the Board) adopted Policy 40-27, which sets forth important new guidelines for providers delivering healthcare services via telehealth technologies, including the ability to...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more
Some of the most commercially successful products to arise out of nanotechnology in terms of sheer size of revenues generated are nanotech drug formulations. This area continues to be hot in the wake of two recent deals, both...more