News & Analysis as of

Human Rights Food and Drug Administration (FDA)

Akerman LLP - Health Law Rx

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of...

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation and Regulatory Update - May 2023

The U.S. Food and Drug Administration (FDA) has written a letter to the manufacturers and developers of new plant varieties, urging them to fully consider the potential ramifications of transferring the genes of allergens to...more

Paul Hastings LLP

Downstream Due Diligence: Regulation through Litigation

Paul Hastings LLP on

As the European Union (“EU”) continues to debate whether downstream responsibilities will fall within the contours of its hefty Corporate Sustainability Mandatory Due Diligence Directive (“CSMDD”), and the EU Council just...more

Holland & Knight LLP

Indian Country Impacted by National Strategy on Hunger, Nutrition and Health

Holland & Knight LLP on

The White House released its National Strategy on Hunger, Nutrition, and Health on Sept. 27, 2022, ahead of the second-ever White House Conference on Hunger, Nutrition, and Health. Specifically, the 44-page paper calls on...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Hogan Lovells

FDA aims to harmonize its human subject protection regulations with Common Rule

Hogan Lovells on

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  ...more

Kilpatrick

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

Kilpatrick on

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

Epstein Becker & Green

Six Key Changes to the Common Rule

Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Mintz - ML Strategies

Africa Update - September 2015 #4

Mintz - ML Strategies on

Leading the News - Burkina Faso: On September 17th, U.S. National Security Advisor Susan Rice condemned the unconstitutional seizure of power by elements of the Presidential Security Regiment in Burkina Faso and...more

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