News & Analysis as of

Clinical Trials Food and Drug Administration (FDA) Prescription Drugs

Morgan Lewis - As Prescribed

FDA Issues Long-Awaited Diversity Action Plan Guidance

Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Holland & Knight LLP

FDA Rejects Application for Psychedelic Drug

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more

Mintz - Health Care Viewpoints

FDA Issues Guidance Intended to Diversify and Enhance Clinical Trial Participation

On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the...more

McDermott Will & Emery

FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance

McDermott Will & Emery on

On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more

Foley Hoag LLP

Action Plans on Diversity: Key Requirements for Certain Clinical Studies

Foley Hoag LLP on

On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more

Epstein Becker & Green

FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans

Epstein Becker & Green on

The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more

King & Spalding

Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

King & Spalding on

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – Q2 2024 – A Quarterly Report on Financing Trends

This report series examines quarterly trends in life sciences venture investment. Key findings for Q1 2024 include: • Life sciences VC deal value in Q1 totaled $7.8 billion, which represents a 22.1% increase in value from Q4...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Goodwin

FDA Launches Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program

Goodwin on

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics Evaluation and Research (“CBER”)...more

McDermott Will & Emery

FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)

On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules on Nursing Home Staffing Standards and Medicaid Access and Quality; FTC Bans Most...

Alston & Bird on

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

Hogan Lovells

Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development - Pilot program offers...

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at...more

Hogan Lovells

2024 Life Sciences & Health Care Horizons

Hogan Lovells on

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more

Morgan Lewis

FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

Morgan Lewis on

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. While the draft...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Morgan Lewis - As Prescribed

Key Issues for Life Science Executives for 2024: JP Morgan Healthcare Conference Takeaways

It is hard to believe that we are already in February and it has been a month since the 42nd Annual JP Morgan Healthcare Conference in San Francisco wrapped. It was a packed four days in which the major players in the life...more

Womble Bond Dickinson

An Update on Medical Research and Legal Battles for Psilocybin

Womble Bond Dickinson on

Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Morgan Lewis

2023 Drugs and Biologics Year in Review: Will FDA's 2023 Evolution Usher in Swift Resolutions for 2024?

Morgan Lewis on

The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more

Hogan Lovells

JPM2024: Investing in preemptive medicine programs

Hogan Lovells on

An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity. Innovators inspired by the promise of...more

Hogan Lovells

JPM2024: What to expect from FDA in an election year

Hogan Lovells on

Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs for advanced medicines using innovative...more

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