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

FDA Announces "Purple Book"

The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

FDA’s 'Purple Book' for Biologics—Patents Not Included

This past week, the Food and Drug Administration (FDA) announced the creation of the “Purple Book,” which will list all biological products, including any biosimilar and interchangeable biological products, licensed by the...more

340B Federal Drug Pricing Program September Update: Self-Disclosures

As part of its ongoing series of monthly 340B Federal Drug Pricing Program (340B Program) integrity updates, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) released an update on...more

What’s In a Name? The Value of Pharmaceutical & Biologic Branding

September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch- Waxman strove to offer consumers the benefits of “rapid...more

Food and Beverage News and Trends - Food and Beverage Alert (US): September 2014

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Poll indicates strong support by parents for school lunch standards. On...more

Substitution allowed? State biosimilars laws are evolving

Biosimilar products have not yet reached the US market, but debates on the laws and regulations that will govern them have been raging for some time. It isn’t just federal law at issue. State law may have a profound impact as...more

FDA Publishes "Purple Book" for Biosimilars

FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products - The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more

Supreme Court Allows POM Wonderful to Sue Coke for False Advertising, Despite Its Apparent Compliance with FDA Regulations

In a unanimous decision, the Supreme Court in POM Wonderful LLC v. The Coca Cola Co. (June 12, 2014) held that the Food, Drug, and Cosmetic Act (FDCA) does not preclude a private party from bringing a Lanham Act claim...more

FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to...more

FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some...more

Defining Innovation In A Changing Healthcare Landscape

The business model that has served the pharma industry so well for 20 years has become expensive and slow. But digital technology and Big Data, says Filip van Elsen, might help the industry reboot its relationship with...more

Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

Government Issues New Rules for Religious Employers, But Health Plans, TPAs, and PBMs are still on the Hook to Provide...

The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). The Department of...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k)...

The U.S. Food and Drug Administration (FDA) has issued a final guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) (“SE Guidance”). The SE...more

Ongoing Reglan Litigation — New Appellate Ruling

Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest...more

Food and Beverage News and Trends

Vermont AG defends the state’s GMO statute. On August 8, the Vermont attorney general filed a motion to dismiss a case brought by food trade groups against the state’s newly enacted statute requiring GMO foods be...more

What KIND of Juice Did They Say It Was?

On July 14, 2014, Northern District of Illinois Judge Sara L. Ellis dealt a blow to putative class action members protesting the use of “evaporated cane juice” to describe sugar in product ingredients lists. Plaintiff alleged...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion...

Laboratory Developed Tests - After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more

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