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Food, Drug and Cosmetic Act The United States Food and Drug Administration

The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set... more +
The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set standards for food and drug safety, and to conduct factory inspections.  The FDCA was amended in 1962 to strengthen drug safety policies and implement new efficacy requirements. In 1976, Congress further amended the FDCA to apply safety and efficacy standards to new medical devices. less -

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

by Shook, Hardy & Bacon L.L.P. on

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

by Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

by McDermott Will & Emery on

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

Look Before You Leap – FDA Issues Warning Letters to Four Cannabis-Based Businesses Over Unlawful Product Claims

While the phrase “Green Rush” has been applied to the recent relaxation of state and local laws pertaining to the sale of medicinal and recreational marijuana, perhaps a more apt phrase is: “Check yourself before you wreck...more

ITC Defers to FDA, Declining to Institute Section 337 Investigation

by Ropes & Gray LLP on

In what represents a departure from typical U.S. International Trade Commission (ITC) practice, the ITC on October 27, 2017 declined to institute a Section 337 investigation based on a complaint brought by Amarin Pharma, Inc....more

Medtronic v. Lohr Has Two Shadows

by Reed Smith on

For over fifty years, the BBC has been chronicling the exploits of that ultimate learned intermediary, Dr. Who. Over the decades, successive Doctors have crossed swords (or sonic screwdrivers) with a wide variety of enemies,...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

by Shook, Hardy & Bacon L.L.P. on

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Double Preemption Win in Amiodarone Litigation

by Reed Smith on

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in...more

FDA Issues Final Drug and Device Classification Guidance

by McDermott Will & Emery on

This week, the FDA published final guidance outlining the agency’s current thinking with respect to the classification of products as drugs or devices, respectively. The final guidance summarizes the agency’s position with...more

These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods

by Arnall Golden Gregory LLP on

FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The violations were discovered during FDA’s inspection of the facility. FDA said...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

Food & Beverage Litigation Update | August 2017 #3

As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Innovator Liability Fails Again

by Reed Smith on

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

by Latham & Watkins LLP on

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...more

U.S. Supreme Court’s Decision Not to Take Certiorari in United States v. DeCoster is a Reminder to the Food and Drug Industries to...

by Liskow & Lewis on

Earlier this year there was hope in the food and drug industries that the Supreme Court would revisit and possibly revise the Responsible Corporate Officer Doctrine, also known as the Park Doctrine, by granting certiorari to...more

FDA Announces New Digital Health Innovation Programs

by Ropes & Gray LLP on

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the Food and Drug Administration (“FDA”) has announced new plans to streamline the development and availability of high...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Boxed Warnings and Adequacy as a Matter of Law

by Reed Smith on

One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

FSMA: What Every Food Industry Executive Should Do & Why

by Strasburger & Price, LLP on

With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process,...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”)...more

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