News & Analysis as of

DOJ continues crack down on dietary supplement industry

In October, Life Sciences Decoded described the increased state and federal scrutiny against the dietary supplement industry, including a lawsuit that the Oregon Attorney General filed against GNC. This scrutiny and...more

Warnings Causation Sinks "Failure to Update" Claim

This post is not from the Dechert side of the blog. “Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

FTC Strikes Again—Company Found to Make False and Misleading Biodegradable Claims

On October 20, 2015, the United States Federal Trade Commission (FTC) released a Final Order with a corresponding Opinion against ECM BioFilms, Inc. (ECM) stating that ECM made false and unsubstantiated environmental claims...more

FTC Announces Red Light on Unqualified “Green Approved” Seals

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental...more

US v Bayer: Randomized Clinical Trials not Required for Dietary Supplement Structure Function Claims – Key Takeaways

In a much anticipated opinion for the dietary supplement industry and for products making health benefit statements, the District of New Jersey in US v. Bayer has found in favor of Bayer in holding that the government failed...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Children's Products and the Consumer Product Safety Improvement Act of 2008: A Synopsis of the Rules and Regulations Governing Toy...

Children's products, including toys, are regulated by the Consumer Product Safety Commission (CPSC) through the Consumer Product Safety Improvement Act of 2008 (CPSIA). Certain sections of CPSIA focus on children's toys....more

Ruling Allows Gerber False Advertising Suit to Crawl Onward

For plaintiffs concerned that the Fourth Circuit Court of Appeals’ June 19, 2015 decision in Brown v. GNC Corp. signaled the muscling in of a stricter new pleading standard for false advertising class actions nationwide, a...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

FTC Green Guides: FTC Sends Warning Letters Concerning Environmental Certification Seals

The Federal Trade Commission (FTC) announced in a September 14, 2015, press release, "FTC Sends Warning Letters about Green Certification Seals," that it sent warning letters to five providers of environmental certification...more

Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court will soon decide whether to grant or deny review of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the...more

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

Advertising Law - September 2015

Third Circuit Affirms FTC's Power to Regulate Data Security Practices - Affirming the power of the Federal Trade Commission to regulate corporate cybersecurity, the Third Circuit Court of Appeals held that the agency may...more

ACA Menu Labeling Requirements: Draft FDA Guidance

The FDA’s 105-page final rule on chain restaurant nutrition labeling of menu items now has an associated, 53-page, draft guidance document, supplementing the FDA’s 132-page Food Labeling Guide, we learned from the September...more

Mandatory GMO Labeling Quashed Under House Bill

In late July, the U.S. House of Representatives passed the Safe and Accurate Food Labeling Act. The controversial legislation, as passed by the House, creates a national voluntary standard for the labeling of foods with GMO...more

Governor Brown signs bill returning California to mainstream on “Made in USA” labeling and providing a potential avenue to end...

A bill signed last week by California Governor Jerry Brown gives manufacturers and retailers a good argument that pending litigation over “Made in USA” labeling should be dead in its tracks. That is the key takeaway from the...more

California Relaxes Its “Made in the U.S.A.” Law

To the consternation of many, California law has long imposed a “Made in the U.S.A.” standard that has been more stringent than the federal standard, requiring manufacturers of all types who wanted to make a country of origin...more

California Joins rest of Country in “Made in USA” Rules

California, the beacon of individualism and often marching to its own set of rules, has joined the rest of the country as Gov. Jerry Brown has signed SB 633 which revises California’s take on what constitutes “Made in USA”....more

Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015) - District Court Finds Lilly Patent Infringed Based on...

Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more

District Court Grants Summary Judgment of No Damages for Failure to Mark

Plaintiff Juno Manufacturing, LLC ("Plaintiff" or "Juno") filed a patent infringement complaint against Defendant Nora Lighting, Inc. ("Defendant" or "Nora"). The complaint alleged that Defendant infringed Plaintiff's patent,...more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more

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