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

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

FDA Proposes Revisions to Food Safety Rules

The updated proposed rules involve produce safety, preventive controls for human and animal food, and the foreign verification program. According to Mike Taylor, deputy commissioner for foods and veterinary medicine, "the FDA...more

FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more

Food Litigation Newsletter - September 2014

In This Issue: - Recent Significant Developments And Rulings ..Voluntary Dismissal in Frito-Lay Pretzel Case ..Court Denies Motion to Dismiss in Florida "Natural" Action ..Court Embraces Standing...more

FDA's Proposed Oversight of Laboratory Developed Tests - Industry Impact

The U.S. Food and Drug Administration (FDA) recently announced that the Agency is lifting its enforcement discretion over high-risk laboratory developed tests (LDTs). The FDA’s “LDT Guidance” was reviewed in detail in my...more

Purple Is the New Orange

Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable biosimilars to be known as the Purple Book. The Purple Book is meant to be the...more

Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...more

FDA Releases Revised FSMA Rules

On September 19, 2014, FDA released four supplementary notices of proposed rule-makings (SNPRMs), revised versions of four of the proposed rules it released previously as part of its implementation of the Food Safety...more

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of...more

Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity

Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests. As the Food and Drug...more

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

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