News & Analysis as of

Food and Drug Administration (FDA) Citizen Petitions

Shook, Hardy & Bacon L.L.P.

Valisure Files Citizen Petition on Alleged Benzene in Benzoyl Peroxide, Triggering Lawsuits

Independent laboratory Valisure filed a March 5, 2024, citizen petition (CP) asserting, based on its own testing, that a number of benzoyl peroxide products contain high levels of benzene and that benzene concentrations are...more

Epstein Becker & Green

Unpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic

Epstein Becker & Green on

Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more

Epstein Becker & Green

Unpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions

Epstein Becker & Green on

This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions.  Make no mistake, I have an interest in this...more

ArentFox Schiff

FDA Reaffirms It Will Not Prohibit Use of Certain Phthalates as Food-Contact Substances

ArentFox Schiff on

On July 21, 2023, the US Food and Drug Administration (FDA) issued a letter denying a request that it reconsider its decision from May 2022 that it would not prohibit the use of eight phthalates as food-contact substances. At...more

Hogan Lovells

FDA to Propose Acacia (Gum Arabic) as a Dietary Fiber

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (gum arabic) as a dietary fiber. As a result of the petition, FDA intends to propose to include acacia,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Boehringer Ingelheim Seeks to Redefine a Biosimilar’s “Strength”

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more

Goodwin

Boehringer Ingelheim Files Citizen Petition Urging FDA to Address “Strength” Definition for Biosimilars, Citing Concerns Over...

Goodwin on

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral...more

Proskauer - Minding Your Business

H.R. 4712: A “Narrowly Tailored” Obligation Under the Orphan Drug Act?

The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l September 2020 #2

The U.S. Food and Drug Administration (FDA) has released a proposed update to traceability recordkeeping requirements for foods considered “high risk” as sources of foodborne illness. The proposed rule would apply to entities...more

Hogan Lovells

Council for Responsible Nutrition Submits Citizen Petition Requesting FDA Rulemaking to Allow CBD and other Hemp-Derived...

Hogan Lovells on

The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...more

Jones Day

Consumer Groups File Petition Urging the USDA to Change Meat Labeling Requirements

Jones Day on

For years, natural sources of nitrates and nitrites have been used to cure meats as an alternative to traditional synthetic sources. The United States Department of Agriculture ("USDA") requires companies that cure meats...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l November 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on Citizen Petitions and Stay of Action Petitions Subject to FDCA Section 505(q)

Introduction: Citizen Petitions in the News - Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2019 #4

LEGISLATION, REGULATIONS & STANDARDS - FDA to Hold CBD Public Hearings - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly said in a February 27, 2019, hearing before the House...more

Hogan Lovells

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

Hogan Lovells on

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more

McDermott Will & Emery

THE LATEST: FTC Submits Comment on FDA Guidance Aimed at Deterring Abuse of Citizen Petition Process

McDermott Will & Emery on

The Federal Trade Commission (FTC) submitted comments supporting the Food and Drug Administration’s (FDA) guidance for assessing whether a pharmaceutical company petitioner is misusing the citizen petition process to delay...more

King & Spalding

FTC Comment on FDA Guidance

King & Spalding on

On December 3, 2018, the Federal Trade Commission (“FTC”) submitted a comment on the Food and Drug Administration’s (“FDA’s”) revised draft guidance regarding the process for reviewing 505(q) citizen petitions (“Revised Draft...more

Cozen O'Connor

Deterring Gaming of the Generic Drug Approval Process by the Use of Citizen Petitions

Cozen O'Connor on

The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often accuse brands of improperly trying to extend their monopolies over patented...more

Goodwin

Pfizer Submits Citizen Petition to FDA Regarding Communications About Biosimilars

Goodwin on

On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.” ...more

Wilson Sonsini Goodrich & Rosati

Federal Court Challenges FTC’s Litigation Authority in FTC v Shire ViroPharma

In a novel interpretation of the Federal Trade Commission (FTC) Act, the U.S. District Court for the District of Delaware recently held in FTC v. Shire ViroPharma that the FTC had failed to plead the facts necessary to invoke...more

Zelle  LLP

The Latest Trends in Drug Monopolies

Zelle LLP on

Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly...more

Goodwin

Updates on Coherus pegfilgrastim and other biosimilar efforts

Goodwin on

We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. ...more

Morrison & Foerster LLP - Class Dismissed

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Goodwin

Apotex Citizen Petition Seeks to Heighten Regulatory Requirements for Biosimilar Competition

Goodwin on

Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that...more

Mintz - Health Care Viewpoints

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

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