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

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

FDA Releases Draft Guidance on its Voluntary Qualified Importer Program

On June 5, 2015, the Food and Drug Administration (FDA) announced the publication of its Draft Guidance on its Voluntary Qualified Importer Program (VQIP). The FDA is establishing VQIP to enable the expedited review and...more

Activities For sNDA and Citizen’s Petition Protected by “Safe Harbor” - Classen Immunotherapies, Inc. v. Elan Pharmaceuticals,...

In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more

FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more

FDA Announced a Four-Month Enforcement Delay on Certain Drug Supply Chain Security Act Product Tracing Requirements for Dispensers

FDA Does Not Intend to Enforce Product Tracing Requirements Related to Dispensers’ Receipt and Maintenance of Product Tracing Information Until November 1, 2015. It Did Not Delay Dispenser Requirements With Respect to Product...more

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

Consumer Food Fraud Claim Sinks in Arkansas Safe Harbor

On this date in 1896 the Dutch completed the harbor at IJmuiden. (That capital J is not a mistake. The I and J go together as a digraph, and they form a ligature that effectively makes up a single letter in the Dutch...more

IEEE Releases Med Device Cybersecurity Guidelines

Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled...more

Unfortunately Disappointing 3D Printing Law Review Article

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing”...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads,...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Beyond Ebola: Environmental Regulatory Issues Creating Business Risks for Health Care Providers

Business and legal risks to health care companies reach far beyond scientific uncertainties in the prevention protocols for infectious diseases due to lack of clarity among regulators with public health...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

HHS Removes Extra Hurdle for Marijuana Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service...more

VertiFlex Announces FDA Approval of Superion Interspinous Spacer System

VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System.  This approval comes after a...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

June Xarelto Update – Science Day

Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a...more

Departments Issue Additional Guidance on Preventive Services

The Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued guidance in the form of FAQs on the ACA’s preventive services mandate. The ACA requires non-grandfathered...more

Blog: FDA Launches New REMS Website

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more

DIA 2015 Provides Panels on All Types of FDA-Regulated Products with Many Opportunities for Insight and Interaction – Part Two of...

On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more

Polsinelli Podcast - Is a Single U.S. Food Agency a Reality? [Video]

In the United States, 2015 has brought forth several regulatory proposals in what has become a perpetual Washington, D.C. conversation: Why is there more than one federal agency responsible for food safety and what can and...more

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