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Food and Drug Administration (FDA) Reporting Requirements

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Foley & Lardner LLP

2024 CPSC and FDA Enforcement Trends

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The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more

Goodwin

FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

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​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

Gardner Law

FDA Unveils Criteria for Reporting Real-World Evidence (RWE) Submissions

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The U.S. Food and Drug Administration (FDA) recently published its criteria for reporting on the use of real-world evidence (RWE) in drug and biologic submissions, as part of its commitments under the Prescription Drug User...more

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

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Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

Mintz - Health Care Viewpoints

Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more

Husch Blackwell LLP

MoCRA: What’s on the horizon for PFAS?

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This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

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On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

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Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

Husch Blackwell LLP

MoCRA: A New Era in the Regulation of Cosmetic Products

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The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the...more

Foley & Lardner LLP

COVID-19 Related Medical Devices: FDA Finalizes Transition Plan Guidance

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On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19...more

Epstein Becker & Green

Reminder of March 31 “Right to Try” Reporting Deadline

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Pharmaceutical companies that have provided investigational drugs to patients under the Right to Try law should be prepared to comply with the U.S. Food and Drug Administration’s (FDA’s) reporting requirements by March 31,...more

Epstein Becker & Green

FDA Significantly Reforms Cosmetics Regulations for First Time in Over 80 Years

In the first major reform of cosmetics regulations since the Federal Food, Drug & Cosmetics Act (FDCA) became law in 1938, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expands the authority of...more

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 1

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Introducing Dechert Re:Torts, a monthly publication that offers a summary of significant cases, rules and pertinent issues, brought to you by Dechert’s Product Liability and Mass Torts Group. Our snapshots help you stay...more

Foley & Lardner LLP

Modernization of Cosmetics Regulation Act of 2022: What You Need to Know

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On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

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The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...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

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Dechert LLP

Not Prescription, Not Merely Over the Counter: FDA Proposes a Novel Category of Drugs

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In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more

Holland & Knight LLP

Holland & Knight Health Dose: July 12, 2022

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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. This week's topics include: ...more

Bass, Berry & Sims PLC

FDA Guidance on Diversity Plans in Clinical Trials: What You Need to Know

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The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more

BCLP

PFAS Update: A Retrospective on Federal PFAS Regulation in 2021

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As anticipated, 2021 was an eventful year for the regulation of per- and polyfluoroalkyl substances (“PFAS”) at the federal level. BCLP has highlighted the key developments in this document, but this is not intended to be a...more

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

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Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more

ArentFox Schiff

New Burdensome FDA Requirements Mandate Reporting Volumes of Almost All Drugs Produced Each Year

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On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more

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