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 -
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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

Advertising Law - Oct 2014

FTC Mows Down Astroturfing at Yahoo - The Federal Trade Commission has closed an investigation into “astroturfing” by Yahoo employees and declined to take enforcement action because of the limited number of workers...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

Growing Michigan - Third Quarter 2014

In This Issue: - Food and Drug Administration Not Required to Ban Antibiotics Given to Food-Producing Animals - U.S. Department of Agriculture Expands Crop Insurance under 2014 Farm Bill -...more

The Supreme Court Continues to Punt on False Claims Cases

The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). ...more

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

Food and Drug Administration Not Required to Ban Antibiotics Given to Food-Producing Animals

A federal appeals court recently ruled that the Food and Drug Administration ("FDA") does not have to ban the practice of feeding antibiotics to healthy, food-producing animals. This ruling is controversial because of public...more

Blog: FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber...more

FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management

On October 2, 2014, the Food and Drug Administration (“FDA”) released the final version of a guidance document entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” As discussed in a...more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

Food and Beverage Alert (US)

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Judge refuses to dismiss “all natural” class action. On September 9, a...more

FDA Outbreak Response Is Not a Constitutional Taking

Food companies are asking whether they can gain compensation from the United States government after a product recall. While the FDA Food Safety Modernization Act (FSMA) does provide for the possibility, a recent ruling by...more

FDA Issues Draft Guidance for Laboratory Developed Tests

For almost 40 years the FDA has regulated in vitro diagnostics (IVDs) as medical devices. An IVD is a reagent, instrument, or system that is intended for the diagnosis of a disease or other condition, including the...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

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