News & Analysis as of

Life Sciences Request For Information

MoFo Life Sciences

Microbes, Biotech Investigations, And Impacts: Midsummer Regulatory Updates From USDA-APHIS

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After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its...more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Jones Day

Medical Payment Products and Health Care Pricing Practices Draw CFPB Attention

Jones Day on

The Consumer Financial Protection Bureau (“CFPB”), Department of Health and Human Services (“HHS”), and United States Treasury have issued an interagency Request for Information (“RFI”) focused on the offering and provision...more

Hogan Lovells

NIH requests feedback on its genomic data sharing policy

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The National Institutes of Health has issued a request for information (RFI) on its Genomic Data Sharing (GDS) Policy to help ensure it keeps pace with the evolving genomic research landscape. The RFI will help inform...more

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

Hogan Lovells on

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...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

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

Hogan Lovells on

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

Morgan Lewis

Calling All Robot Enthusiasts: The White House Wants Your Input

Morgan Lewis on

White House issues an RFI on the legal and governance implications of artificial intelligence. On June 27, the US Office of Science and Technology Policy (OSTP) issued a Request For Information on Artificial Intelligence...more

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