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

HHS Issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission. The...more

Restaurant Franchisors: Prepare to Comply With New FDA Menu Labeling Rules

The U.S. Food and Drug Administration (FDA) released its final rules for menu labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive health care reform...more

Sandoz Was Disinvited to the Patent Dance: The Federal Circuit's First Interpretation of the BPCIA Will Have to Wait

Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

Focus Newsletter - December 2014

In this issue: - ABC's of a Product Recall - Amazing Clients® Lumenpulse Inc. - A Bright Future for a Company That Is Lighting Up the World - Delaware Corporate Law Becomes More User-Friendly -...more

Post Wisely

Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums - Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social...more

FDA Science Chief Reports Quicker Medical Device Clinical Trial Approvals

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel- the science chief of the U.S. Food and Drug Administration’s center to oversee approval of...more

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Vermont Doubles Down: Representative Testifies Before Congress Against Federal GMO Labeling Bill

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

Federal Circuit Gives Little Guidance on Biosimilar Patent Validity Challenges

Recently, the Federal Circuit had the opportunity to issue its first decision relating to biosimilars patent litigation and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) procedures. Instead, the court...more

Advertising Law - December 2014 #2

Uber’s Privacy Mess Results in Legislative Inquiry - Providing a lesson in how not to handle a privacy policy, car service app Uber is now facing questions from the Senate Subcommittee on Privacy, Technology and the...more

House Committee Hearing Debates "GMO" Labeling Bill

On December 10, 2014, the U.S. House Energy & Commerce Subcommittee on Health held a hearing on Examining FDA's Role in the Regulation of Genetically Modified Food Ingredients. The witnesses included Michael Landa, Director...more

Court Allows “Product Hopping” Claims to Proceed in Suboxone Litigation Based on Allegations of Removal of Prior Formulation and...

We’ve previously discussed antitrust claims related to “product hopping”—allegations that pharmaceutical manufacturers have reformulated or otherwise altered their products to prevent automatic generic substitution. Earlier...more

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to...

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory...more

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision...more

Federal Circuit Affirms Dismissal in Sandoz v. Amgen under Traditional Jurisdictional Grounds and Declines First Opportunity to...

In the first Federal Circuit case involving the Biologics Price Competition and Innovation Act (“BPCIA” or “Biosimilars Act”), the Court of Appeals for the Federal Circuit affirmed Judge Maxine E. Chesney’s (N.D. Cal.)...more

Health Headlines: Also in the News - December 2014

CMS Extends Comment Period for Home Health Conditions of Participation Proposed Rule – As previously reported, on October 9, 2014, CMS published in the Federal Register a Proposed Rule that would revise the home health...more

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include...more

Health Care Reform Implementation Update

We are now more than two weeks into the Affordable Care Act (ACA’s) second open enrollment period, and 765,000 individuals have obtained coverage through HealthCare.gov. On Capitol Hill, House lawmakers filed a lawsuit...more

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

New York District Court Dismisses Biosimilar Applicant’s Declaratory Judgment Action for Lack of Jurisdiction

In a recent lawsuit between a biosimilar applicant and a patent owner, Judge Paul A. Crotty (S.D.N.Y.) relied on Sandoz Inc. v. Amgen Inc., 3:13-cv-02904-MMC (N.D. Cal. Nov. 12, 2013) to deny declaratory relief for the...more

Insurance Recovery Law -- December 2014

Texas Appeals Court Upholds $8.7M Verdict for Policyholder Against Broker - Why it matters: An appeals court in Texas upheld an $8.7 million jury verdict against a broker that procured coverage with significant...more

935 Results
|
View per page
Page: of 38