News & Analysis as of

Abbreviated New Drug Application (ANDA) Department of Health and Human Services (HHS)

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Alston & Bird

Health Care Week in Review: CMS Issues Rules on FY 2025 Payment Rates; Medicaid Enrollment; and Short-Term, Limited Duration...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Alston & Bird

Health Care Week in Review: Rep. McCarthy Ousted as Speaker of the House; CMS Announces Drug Manufacturer Participation in...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Alston & Bird

Health Care Week in Review: CMMI Model and IRA Part B Drug List

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMMI Announces Three New Models, President Biden Issues Executive Order

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

ArentFox Schiff

New Challenge to Abortion Access Takes on FDA Drug Approvals

ArentFox Schiff on

On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Foley Hoag LLP on

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #4

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - November 2021 #2

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - May 2021 #4

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

King & Spalding

FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates

King & Spalding on

Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more

Alston & Bird

Alston & Bird Healthcare Week in Review - March 2020 #2

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Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Wilson Sonsini Goodrich & Rosati

FDA Prioritizes Review Generic Drug Products to Treat Opioid Overdose

Introduction: The Opioid Crisis - Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing,...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

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President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Holland & Knight LLP

The Government Shutdown and Its Effects on the FDA

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Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more

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