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Healthcare › Manufacturers › Comment Period

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

Sheppard Mullin Richter & Hampton LLP on

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Troutman Pepper Locke

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper Locke on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Hogan Lovells

UK MHRA to develop quality standards for biological medicines

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

Polsinelli

New 340B Dispute Resolution Process: Will It Level the Playing Field?

Polsinelli on

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more

Robinson+Cole Data Privacy + Security Insider

NIST issues Draft Framework for Cyber-Physical System

Robinson+Cole Data Privacy + Security Insider on

On September 18, 2015, the National Institute of Standards and Technology (NIST) issued its draft Framework for Cyber-Physical Systems (CPS), which is “intended to provide a methodology for understanding, designing and...more

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