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

Lack of Federal Regulation in Cosmetics and Personal Care Products Leads to Litigation Risks

In recent years, consumers have become more focused on the potential for health risks associated with the use of chemicals and other ingredients in cosmetics and personal care products. Many consumers, however, may not...more

Sweet(ener) Confusion: Court Divide Over Role of Primary Jurisdiction Doctrine in “Evaporated Cane Juice” Cases Grows

In Swearingen v. Santa Cruz Natural, Inc., No. C 13-04291 (N.D. Cal. April 2, 2014), Judge Illston of the U.S. District Court for the Northern District of California granted defendant’s motion to dismiss based on the primary...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

Part II: Fair Notice or No Notice? The Wyndham Worldwide Case and the Expanding Power of the FTC to Police Data Security

In our first blog in this series, we provided a summary of the District Court of New Jersey’s recent decision in FTC v. Wyndham Worldwide Corp., in which Judge Salas confirmed the FTC’s authority to bring enforcement actions...more

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To...more

API Manufacturers Are Not Proper Defendants In Hatch-Waxman Actions

A district court judge in New Jersey recently granted an API supplier’s motion to dismiss claims filed against the supplier in an ANDA suit, raising questions about whether an API supplier belongs as a defendant in these...more

Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

Chicago Extinguishes E-Cigarette Use In Enclosed Places

The city of Chicago has decided that electronic cigarettes (e-cigarettes) should be treated the same way as more conventional cigarettes. Effective April 29, 2014, e-cigarettes will be banned in enclosed public places and...more

Sixth Circuit Affirms Dismissal of Securities Class Action for Failure to Properly Plead Scienter

On March 28, the US Court of Appeals for the Sixth Circuit affirmed a lower court’s dismissal of a shareholder class action against BioMimetic Therapeutics Inc., finding that plaintiffs had failed to sufficiently allege that...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

Weight Loss Supplement Alli Recalled Nationwide

Just to be safe, drugmaker GlaxoSmithKline (GSK) Consumer healthcare will remove all of its weight loss drug alli from stores shelves in the U.S. and Puerto Rico due to fear of contamination. There have been at least 20...more

FDA Reports Rise in Medical Device Recalls and Warnings

This news is not surprising to anyone who pays attention to medical device recalls. There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division...more

Harvard Researchers Take FDA Approval of Implantable Cardiac Devices to Task

Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to...more

Out of the Box: Legal guidance for the consumer product + retail industry - Volume 2, Issue 1, Spring 2014

In This Issue: - California Announces First Consumer Products Subjected To New Green Chemistry Rules - FDA Issues Final Guidance Distinguishing Liquid Dietary Supplements from Beverages - Private Surgeon General...more

Food and Beverage News and Trends - April 2014

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Food industry opposes trans fat bar, proposes setting limitations. Major...more

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more

Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

Congressional Hearing on Proposed FDA Rule Change

Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling....more

Health Care on the Hill: April 2014

House Committee on Energy and Commerce – Subcommittee on Health - “Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling” - April 1, 2014 – 3:00pm - 2322 Rayburn House Office...more

Court Issues Sweet Ruling for Plaintiffs in Mislabeling Action – Ignorance That “Evaporated Cane Juice” Is An Added Sugar Not...

In Morgan v. Wallaby Yogurt Co., Inc., the U.S. District Court for the Northern District of California denied defendant’s motion to dismiss a class action complaint alleging violations of the UCL, FAL, and CLRA for...more

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