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Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

Quarles & Brady LLP on

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...

Epstein Becker & Green on

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

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 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

McDermott Will & Emery

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

McDermott Will & Emery on

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2015

Bergeson & Campbell, P.C. on

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

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