Search Results: Health Care

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Psychedelics & Drug Development — Key Considerations for Healthcare Industry and Life Sciences Companies as Congress Seeks to Tap Into Psychedelics’ Therapeutic Potential

Based on recent regulatory changes at the state and local level and the efforts by the federal government and certain foreign agencies, investors, clinical trial sponsors, life sciences companies, and investigators operating in the psychedelics industry may have reason to be optimistic about the future regulatory landscape for therapeutic psychedelic…

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Seven Tips for Healthcare & Life Sciences Companies Engaging Independent Monitors and Compliance Experts

For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance expert may become a reality. (We collectively refer to all of these individuals and entities as monitors throughout this update.) Hiring…

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The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data Protection

We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the major elements of the proposals is a change to the period of regulatory data protection for…

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DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances

Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person visit with a patient, subject to certain conditions as outlined in our earlier blog post. Additionally, DEA waived the requirement…

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The ABCs of DCTs: New FDA Guidance Provides Recommendations for the Conduct of Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). The Draft Guidance expands on the FDA’s 2020 recommendations issued in response to the COVID-19 pandemic and its 2021 draft guidance on the…

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DEA Announces Temporary Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those exceptions include prescriptions issued during a public health emergency. Thus, since the January 31, 2020 declaration of a public health…

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The MHRA Proposes to Extend the Period of Acceptance of CE Marked Medical Devices in Great Britain Beyond 30 June 2023

BACKGROUND On 28 April 2023, the UK’s medical devices regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), announced its intention to extend the acceptance of CE marked medical devices in Great Britain (England, Scotland and Wales) beyond 30 June 2023. Following the UK’s departure from the EU, CE marked…

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FDA Issues Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance

The U.S. Food and Drug Administration recently issued its draft guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” The draft guidance follows the passage of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which explicitly authorized the…

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The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years

On 26 April 2023, the European Commission published two legislative proposals – a new Regulation 2023/0131 and a new Directive 2023/0132 – to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). The Directive contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing…

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FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft guidance (the “Draft Guidance”) of the same name and expands on (but does not supersede) the FDA’s August…

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