News & Analysis as of

Life Sciences Licensing Rules

McDermott Will & Emery

Trending in Telehealth: February 5 – 12, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Quarles & Brady LLP

Are You Ready for Alabama’s New Designated Representative Requirements?

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In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...more

McDermott Will & Emery

Trending in Telehealth: November 8 – 14, 2023

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Emery

Trending in Telehealth: October 24 – 31, 2023

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Quarles & Brady LLP

Nevada Legislature Rejects Board of Pharmacy’s Licensing Requirement for Out-of-State Pharmacists

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On May 31, 2023, the Nevada Legislature enacted Assembly Bill 107, which reversed the Nevada Board of Pharmacy’s (the “Board”) interpretation that required Nevada pharmacist licensure for out-of-state pharmacists who dispense...more

American Conference Institute (ACI)

Tips for Entering the Life Sciences Market in Brazil

For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will...more

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

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Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

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On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Quarles & Brady LLP

Georgia Board of Pharmacy Continues to Review Licensure Requirements for Pharmacists

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At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

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The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

Quarles & Brady LLP

California Board of Pharmacy Changes

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Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Biosimilar Guidance for Label Carve-Outs and Supplements

On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more

Morgan Lewis

NRC Issues Guidance to Nuclear Materials Licensees in Response to Recent Medical Events

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The NRC’s Office of Nuclear Reactor Regulation and Office of Nuclear Material Safety and Safety and Safeguards recently issued two Information Notices (INs) in response to medical events arising from the administration of...more

Hogan Lovells

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

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

Hogan Lovells

The South African pharmaceutical regulatory environment

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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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