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

The Contraception Coverage Controversy Continues…

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e....more

FDA and the Center for Food Safety Reach Settlement Regarding FDA’s GRAS Rule

On October 20, 2014, FDA reached a settlement with the Center for Food Safety (“CFS”) in litigation pending in the U.S. District Court for the District of Columbia. This litigation is related to FDA’s rule for food additives...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

Pom Wonderful Drops Ninth Circuit Appeal of State Claims Filed Against Coca-Cola

On September 19, 2014, Pom Wonderful, LLC dropped its Ninth Circuit appeal of a ruling that dismissed its state deceptive advertising and unfair competition claims against Coca-Cola, a sibling case to a recent Supreme Court...more

FDA Releases Final Cybersecurity Guidance for Medical Devices

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

Health Care Update - October 2014 #4

In This Issue: - Ebola Response Taking a Multifaceted Approach - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional Initiatives - Other...more

FDA Flunks Data Security Exam

Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more

FDA Issues Cybersecurity Guidelines - Manufacturers of Medical Devices Encouraged to Develop Cybersecurity Controls

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or...more

Advertising Law - October 2014 #3

Permanent Ban From Prize Promotion Business After Sweepstakes Scam - A sweepstakes operator agreed to a permanent ban from the prize promotion business pursuant to a settlement with the Federal Trade Commission after...more

FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions - Restrictions Loosened but Exemption Remains Narrow

On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Commentator says “food addiction” is a misleading term that should not be...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

California Court Has a Bone to Pick with Male Enhancement Pill Maker

We try to avoid puns in this blog but sometimes, well, we just can’t help it. The makers of “Rockhard Weekend,” a male sex enhancement pill, have successfully sidestepped a claim that they violated federal drug...more

Battle of the Experts Still Brewin’ in Starbucks Trial

In April 2010, the Council for Education and Research on Toxics (CERT) sued Starbucks Corp. and other coffee sellers alleging they violated California’s Safe Drinking Water and Toxic Enforcement Act, passed by California...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all...more

The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

Health Headlines: Also in the News - October 2014

On September 30th, the Food and Drug Administration (FDA) released draft guidance concerning the proposed oversight framework for regulating laboratory developed tests....more

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

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

School Nutrition Association responds to critical article, sets forth its views on healthy lunches. The School Nutrition Association, which represents school cafeterias across the nation, responded on October 7 to a New York...more

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