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Request For Information Food and Drug Administration (FDA)

Holland & Knight LLP

Holland & Knight Health Dose: May 20, 2025

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The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more

Venable LLP

Operation Stork Speed Update: FDA Issues RFI for Infant Formula Nutrition Review

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On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more

Holland & Knight LLP

HHS, FDA Issue Request for Information to Support Administration's Deregulatory Agenda

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The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more

Perkins Coie

FDA and USDA Seek Comments on Standardizing Food Date Labeling

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The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) recently published a joint Request for Information (RFI) seeking stakeholder input related...more

Gardner Law

Responding to CIDs and Other Government Information Requests: A Practical Guide for FDA-Regulated Companies

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Understanding Your Obligations and Protecting Your Rights - Government investigations are a reality for businesses operating in FDA-regulated industries. While the previous webinar focused on general preparedness, this...more

Alston & Bird

Health Care Week in Review: CMS Publishes 2025 MA and Part D Star Ratings and Releases RFI on Medicare $2 Drug List Model

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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

Perkins Coie

USDA APHIS Invites Stakeholder Comments on Regulation of Modified Microbes

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In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more

ArentFox Schiff

USDA’s Biotechnology Regulator Issues Much-Anticipated RFI on Regulation of Modified Microbes

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On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically...more

Alston & Bird

Health Care Week in Review: CMS Announces Data RFI to Improve Medicare Advantage Transparency; Senate Finance Committee Releases...

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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

Foley & Lardner LLP

CPSC Signals its Regulatory Interest in PFAS

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On September 20, 2023, the Consumer Product Safety Commission (CPSC) issued a Federal Register Notice and Request for Information asking for public comment about the use and presence of per- and polyfluoroalkyl substances...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

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THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Holland & Knight LLP

Congressional Leaders Seek Stakeholder Input Regarding CBD Regulation

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The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more

Cozen O'Connor

AGs Question FDA Plan for Mail-Back Opioid Program

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13 Republican AGs wrote a letter to the FDA in response to its Request for Information regarding “In-Home Disposal Systems for Opioid Analgesics,” a proposed mail-back program for leftover opioid products....more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #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

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

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On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

Wiley Rein LLP

Labeling of Foods Comprised of or Containing Cultured Seafood Cells: FDA Requests Public Comment

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The U.S. Food and Drug Administration (FDA) published a request for information in the Federal Register in connection with labeling of foods made with cultured seafood cells. FDA will use the information received to decide...more

Hogan Lovells

FDA requests information on labeling of cell-cultured seafood

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The U.S. Food and Drug Administration (FDA) is requesting public comment on the labeling of seafood products made using cell culture technology. FDA’s Request for Information (RFI) entitled, “Labeling of Foods Comprised of or...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Holland & Knight LLP

FDA Publishes Consumer Update on Cannabis Products, Including CBD

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On June 14, 2019, the FDA published a Consumer Update entitled "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD." In the Update,...more

Hogan Lovells

FDA Issues Request for Information Regarding Sesame as an Allergen in Foods

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The U.S. Food and Drug Administration (FDA) recently issued a request for information seeking data and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | October 2018

LEGISLATION, REGULATIONS & STANDARDS - FDA Seeks Input on Plant-Based Milks - The U.S. Food and Drug Administration (FDA) has solicited public input on questions related to plant-based substitutes for dairy products...more

Hogan Lovells

FDA Issues Request for Information Regarding Use of Names of Dairy Foods in the Labeling of Plant-Based Products

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The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one...more

Hogan Lovells

FDA Proposes New Rule to Increase Transparency and Access to Agency Documents Under FOIA

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The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule...more

Foley & Lardner LLP

The Battle Over Drug Pricing: First Shot Targets Pharmacy Benefit Managers

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On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

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