Clinical Trials The United States Food and Drug Administration

News & Analysis as of

Newly Released FAQs Address Health Plan Compliance Issues

The questions address a wide range of issues, including preventive care, coverage for clinical trials, required disclosures, the Women’s Health and Cancer Rights Act, rescissions, reference pricing and mental health parity...more

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

Second Circuit Affirms District Court in Tongue v. Sanofi

On March 4, 2016, the United States Court of Appeals for the Second Circuit affirmed the District Court for the Southern District of New York in Tongue v. Sanofi, No. 15-588-CV, 2016 WL 851797 (2d Cir. Mar. 4, 2016), holding...more

The Proponent Testimony Goes Unrefuted As Renowned Physician Dr. Sue Sisley Highlights The Testimony Of Ten Witnesses Before The...

Thursday, February 17, 2016, was the first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”), which heard a full complement of testimony, all in support of legalizing medical...more

Xarelto Litigation – February Updates

There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the...more

FDA-regulated industries: Plan now for these changes in 2016

In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare...more

The Food and Drug Administration Announces a Stay Related to IND Guidance

On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech

Halloween has come and gone. The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest. There was ample candy –...more

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

A&B Healthcare Week In Review, September 2015

On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

FCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing

On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio...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

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

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