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Regulatory Agenda › Rulemaking Process › Prescription Drugs

McCarter & English, LLP

DEA Telemedicine Update

McCarter & English, LLP on

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

Akin Gump Strauss Hauer & Feld LLP on

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

McDermott Will & Schulte

Of Digital Interest Quarterly Roundup | Q1 2023

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McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more

Robins Kaplan LLP

[Webinar] Health Care Antitrust Under President Biden 2.0 - Almost One Year In: What Have We Learned About The Democrats’ Approach...

Robins Kaplan LLP on

In March 2021, our experienced intellectual property, antitrust, and health care litigation lawyers shared some predictions on antitrust policy and enforcement in the health care sector. In “Health Care Antitrust under...more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022

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In an evening email that is sure to ruin the weekend for many, CMS announced on February 5, 2020, that it is proposing changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022. CMS will not issue a Call...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

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This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

Akerman LLP - Health Law Rx on

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

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