New Approach for Biologic and Biosimilar Names
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products...
View ArticleCongressional Committees Propose Restructuring of User Fees in Draft Language
The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of...
View ArticleLawsuit Challenges GRAS Rule on Food Substance Safety
Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....By: Kathleen Sanzo
View ArticleFDA Releases Major New Food Safety Proposals
Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....By: Kathleen Sanzo
View ArticleFDA Flexes Its FSMA Muscles, Initiates Mandatory Recall
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority. On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement...
View ArticleFDA Releases Good Manufacturing Practices for Animal Food
Proposed requirements dictate a substantial upgrade of the current regulatory standard of care. On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current...
View ArticleWhat Is That in Your Beverage? And Wait—Is It Really a Beverage?
FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance. On January 14, the U.S. Food and Drug...
View ArticleFTC Cracks Down on False Advertising in Dietary Supplements
Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising. Recent Federal Trade Commission (FTC) enforcement...
View ArticleFDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor
FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....By: Kathleen Sanzo
View ArticleFDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy
New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed...
View ArticleFDA Proposes Tobacco Products Rule; E-Cigarettes, Cigars To Be Regulated
The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require...
View ArticleFDA Rule Prohibits Certain Nutrient Content Claims for Omega-3 Fatty Acids
The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for...
View ArticleFood Companies Should Expect More False Advertising Claims
The Supreme Court holds that competitors may bring Lanham Act claims challenging food and beverage labels that are regulated by the FDA....By: Kathleen Sanzo
View ArticleFSIS Proposes New Recordkeeping Requirements for Ground Beef...
The proposal, if adopted, will require new recordkeeping by both processing establishments and retail facilities that grind raw beef products....By: Kathleen Sanzo
View ArticleFDA Issues Updated Draft Guidance on Reporting Drug Samples
The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment...
View ArticleLiquid Nicotine—New Warnings and Packaging?
FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine. On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking...
View ArticlePractical Implications from Amarin
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally...
View ArticleFDA and Amarin Reach Settlement on First Amendment and Off-Label Statements
FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma,...
View ArticleFollow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around...
View ArticleFDA Issues Menu Labeling Final Guidance
The enforcement date will likely begin in May 2017. The US Food and Drug Administration (FDA) issued its final guidance on April 29 on Menu Labeling (Final Guidance). Importantly, the FDA intends to...
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