News & Analysis as of

Regulatory Agenda Rulemaking Process Life Sciences

Latham & Watkins LLP

100 Days In: FDA Updates and Trends to Watch

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Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

Quarles & Brady LLP on

‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more

Vicente LLP

Psychedelics and Mental Health Therapy in Colorado: DORA and Potential Regulatory Response

Vicente LLP on

Recent psilocybin studies have generated significant interest due to the unparalleled positive results for individuals suffering from major depressive disorders and substance abuse disorders. In an era where once-illicit...more

McDermott Will & Schulte

Special Report - The Future of AI Regulation: The Government as Regulator and Research & Development Participant - Part 1 of 2

Artificial intelligence (AI) systems have raised concerns in the public—some speculative and some based in contemporary experience. Some of these concerns overlap with concerns about privacy of data, some relate to the...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

King & Spalding

Emerging Regulation, Enforcement, and Litigation Involving Ethylene Oxide, a Critical Substance for Sterilizing Medical Products...

King & Spalding on

Ethylene oxide (“EtO”), one of the most widely used and effective substances for sterilizing medical products and devices, has come under intense scrutiny by the Environmental Protection Agency (“EPA”), the Food and Drug...more

Hogan Lovells

CMS Innovation Center seeks input on Oncology Care Model sequel

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In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care Model (OCM). ...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

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Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Hogan Lovells

New draft guidance on MR compatibility for medical devices

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The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

Hogan Lovells

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

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On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

Hogan Lovells

Regulator proposes reducing requirements for radiation-emitting products

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In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices. ...more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

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With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

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Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

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