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Disclosure Requirements › Reporting Requirements › Food and Drug Administration (FDA)

Perkins Coie

Caffeine Safety Legislation Introduced in Congress

Perkins Coie on

On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more

Morgan Lewis - As Prescribed

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Health Care Compliance Association (HCCA) on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Mintz - Health Care Viewpoints

Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

Mintz - Health Care Viewpoints on

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more

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