News & Analysis as of

Life Sciences Comment Period Prescription Drugs

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

McDermott Will & Schulte

FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance

On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

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The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Nelson Mullins Riley & Scarborough LLP

FDA Establishes Public Docket Soliciting Comments on Nitrosamine Drug Substance-Related Impurities

The U.S. Food and Drug Administration (FDA) announced the establishment of a docket requesting public comments on the identification, assessment, and control of N-nitrosamine drug substance-related impurities (NDSRIs) in drug...more

Goodwin

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

Goodwin on

On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more

BakerHostetler

FDA Issues Draft Guidance for Decentralized Clinical Trials

BakerHostetler on

On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more

Jones Day

FDA Proposes IND Exemptions for Drug Studies of Foods, Supplements, or Cosmetics

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Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more

Hogan Lovells

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

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On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

Quarles & Brady LLP

Hot Off the Press: Mississippi Board of Pharmacy Files Proposed Rule on Shared Pharmacy Services

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On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more

Quarles & Brady LLP

FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

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The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more

Quarles & Brady LLP

Texas Board of Pharmacy to Review Central Fill Rules for Potential Change

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At its upcoming February 1, 2022 meeting, the Texas Board of Pharmacy will review and discuss a potential rule change that may have serious implications for resident Texas pharmacies providing central fill or prescription...more

Hogan Lovells

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

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On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

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In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Hogan Lovells

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

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On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more

Hogan Lovells

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

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On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more

Hogan Lovells

340B program: Proposed rule would accelerate the effective date of the CMP Final Rule from July 1, 2019, to January 1, 2019

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This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more

Hogan Lovells

Administration presents plans to lower drug prices

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On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

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