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Foley Hoag LLP - Cannabis and the Law

U.S. Virgin Islands Opens Adult-Use Cannabis License Application Process

On April 17, 2024, the Virgin Islands Cannabis Advisory Board (“VICAB”) approved regulations outlining the requirements for its new adult-use cannabis program, including details regarding the competitive merit-based...more

McDermott Will & Emery

Semiconductor Industry Receives Long-Awaited Tax Credit Guidance From Treasury

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On October 22, 2024, the US Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) issued long-awaited regulations implementing the advanced manufacturing investment credit under Sections 48D and 50...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

White & Case LLP

The EU’s CBAM Implementing Regulation is ready; are you?

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The EU's Carbon Border Adjustment Mechanism (the "CBAM") reporting obligations started applying from 1 October 2023. The final CBAM Implementing Regulation introduces further insight and key clarifications. The CBAM...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more

White & Case LLP

New EU Batteries Regulation: introducing enhanced sustainability, recycling and safety requirements

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A new batteries regulation will impact the design, production and waste management of all types of batteries manufactured or sold in the European Union. The new rules extend producer responsibility and require due diligence...more

White & Case LLP

Four things to know when preparing for EU Carbon Border Adjustment Mechanism reporting

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The application of the EU's Carbon Border Adjustment Mechanism ("CBAM") is fast approaching for importers and manufacturers of products in the cement, fertiliser, iron, steel, aluminium, hydrogen and electricity producing...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Jenner & Block

Client Alert: PFAS in Consumer Products: Developing a Proactive and Strategic Game Plan

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Per- and polyfluoroalkyl substances (PFAS) in consumer products continue to be in the regulatory and litigation spotlight in 2023. Manufacturers and downstream businesses should be actively preparing to comply with the...more

Morgan Lewis

CARB Calls on Motor Vehicle Industry to Self-Report Regulatory Violations

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Citing recent investigations and new emissions detection capabilities, the California Air Resources Board (CARB) urges automakers and equipment manufacturers to voluntarily disclose potential violations of regulatory...more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

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This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

Hogan Lovells

EU Commission seeks feedback on implementing the new Market Surveillance Regulation

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The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more

Hogan Lovells

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

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On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

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Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

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With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

Hogan Lovells

What would a no-deal Brexit look like for the UK chemicals industry?

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The UK government has recently published a technical notice to guide businesses that produce, register, import or export chemicals on what they will need to do if the UK leaves the EU in March 2019 in a 'no deal' scenario...more

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