The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Health Care Update - November 2015 #3

Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

Keeping it Legal: Managing FDA Compliance for Consumer-Generated Content

Social technology platforms allow manufacturers to leverage consumer-generated content about their products (“CGC”) more easily than ever before. Such CGC generally takes the form of written testimonials and product reviews...more

Post-Approval Quality Control Testing of Pharmaceutical Products: What Constitutes 35 U.S.C. § 271(g) Infringement or Falls Under...

The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

FDA Seeks Input on Uses of “Natural” in Food and Beverage Labeling

Earlier this month, the U.S. Food and Drug Administration (FDA) invited public comments on uses of the term “natural” in food and beverage labeling and whether “natural” should apply only to “unprocessed” foods. The FDA’s...more

FDA data underscores why patients need to ask tough questions about care

The epidemic of overtreatment is hardly new, and it often stems from physicians’ tendency to order excessive tests. But now Uncle Sam is getting ready to step in even more, prompted in part by disturbing data that detailed...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

Naming of Interchangeable and Biosimilar Biological Products Likely to Be Same

Earlier this fall, FDA issued a draft guidance proposing a middle-road approach to naming biosimilars. Unlike small-molecule drugs, where the branded and generic drug share the same nonproprietary name (also referred to as a...more

FDA Seems Ready to Weigh In on “Natural” Food Labeling

In 1960, Judge Friendly famously began an opinion by asking, “What is chicken?” Today, the question is, “What is ‘natural’?” Courts today are filled with cases claiming that foods labeled as “natural” are misleading...more

Food for Thought: FDA Approves Genetically Engineered Salmon

On November 19, the U.S. Food and Drug Administration approved genetically engineered (GE) salmon for consumption as food. AquaBounty Technologies, Inc. filed an application with the FDA for the approval of AquAdvantage...more

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients....more

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

J & J Files Cert Petition in Massachusetts Supreme Court’s Unsupportable Rejection of Preemption Defense in Reckis TEN/Children’s...

Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015). As...more

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal...more

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants. The final...more

FDA, Naturally (and Finally), Requests Comments on Use of Term “Natural”

On Nov. 12, 2015, the U.S. Food and Drug Administration (FDA) issued a request for information and comments about the use of the term “natural.” Food and beverage companies have been using the term with few...more

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S....more

FDA Issues New Food Safety Rules

The U.S. Food and Drug Administration (“FDA”) issued three new rules on November 13 implementing the 2011 Food Safety Modernization Act. The Final Rule on Produce Safety establishes microbial water quality standards for water...more

Naturally, It’s Only Natural. Or, Is It?

Think of that busy mom in a grocery store, standing in front of a wall of granola bars. How does she choose which one to buy? Does she pick the all-natural chocolate peanut butter kind or the not-all-natural chocolate peanut...more

FSMA Comes Down on the Farm: FDA Finalizes Produce Safety Standards

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released the prepublication version of its final rule regarding Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human...more

It Will Only Cost You an Audit: FDA Releases FSMA Third-Party Certification Rule

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications...more

Food from Faraway Lands: FDA Releases FSMA Foreign Supplier Food Safety Rule

On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Foreign Supplier Verification Programs for Food Importers (FSVP Rule). The new rule requires importers to ensure that...more

FDA Seeks Comments on the Meaning of “Natural”

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive...more

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

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