Clinical Trials

News & Analysis as of

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

New Obamacare Benefit Mandate Takes Aim at Breast Cancer

Under the Affordable Care Act, insurers and employers that sponsor non-grandfathered medical plans must cover and pay the full cost of specified preventive services in accordance with recommendations issued by the U.S....more

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

New Clinical Trial Rules in the EU: A First Overview

Last week, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was published in the Official Journal of the European Union. The Regulation establishes a single, EU-wide harmonised set of rules...more

Doctors Settle SEC Insider Trading Charges

The Commission filed two settled insider trading cases against medical practitioners who traded while in possession of material non-public information regarding clinical trials for a drug. SEC v. Lama, Case No. 5:14-cv-00996...more

Inch-by-Inch: FDA's New Biosimilars Guidance Inches the Industry Closer to Clinical Testing Clarity

For those under cloudy skies for two years, even a small break in the clouds would seem like a bright sunshiny day. The U.S. Food and Drug Administration's (FDA) newest draft guidance on demonstrating biosimilarity largely...more

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

FDA Releases Warning Letters to Providers Concerning Clinical Trial Supervision

The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more

SEC Files Another Settled Insider Trading Case

Insider trading continues to be a key priority in the new get tough enforcement era. Last week closed with the filing of an insider trading action centered on the BP oil spill in the Gulf of Mexico. This week begins with...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

Pro Te: Solutio Vol. 6 No. 2

In This Issue: - Forum Non Conveniens: How To Avoid The Tide of Lawsuits Brought by Foreign Nationals - Pro Te Solutio: Product Defense And FDA Compliance - Health Care Strike Force: Uncovering Fraud In The...more

European Union Negotiations Reach Agreement on New Clinical Trials Regulation

The European Union (“EU”) has cleared the way for adoption of a new clinical trials regulation within the EU. On December 20, 2013, the Committee of Permanent Representatives of the European Union endorsed proposed revisions...more

Council of the European Union and European Parliament Agree on Proposal for New Clinical Trials Regulation

When Approved by the European Parliament, the Regulation Will Have the Force of Law in All EU Member States and Repeal the Current Clinical Trial Directive - On December 20, 2013, the General Secretariat released the...more

CMS "Packages" Clinical Laboratory Tests Into Outpatient Prospective Payment System

Hospitals Lose Right to Bill Separately for Laboratory Tests for Outpatients - As part of its calendar year 2014 hospital outpatient prospective payment system (OPPS) policy changes, the Centers for Medicare & Medicaid...more

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

Access to clinical trial data: The Italian perspective

There is an increasing trend towards the full publication of data resulting from clinical trials sponsored by the industry. This was the topic of a discussion between the Working Group of the American Chamber of Commerce in...more

China Releases Vaccine Good Clinical Practices

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

The Cost Of Stupid Is Less Than The Cost Of Bribery And Corruption

After the butt-slide play, you might think that the sad sack Houston Astros could not sink even lower but I guess setting the Major League Baseball (MLB) record for the worst record for three straight years is not enough....more

Clinical Trial Number Required on Medicare Claims Effective January 1, 2014

Effective January 1, 2014, CMS will require providers and suppliers to report an 8-digit clinical trial number on claims for items or services furnished pursuant to clinical trials that qualify for coverage as set forth in...more

CMS Issues Proposed CY 2014 Medicare Physician Fee Schedule (MPFS) Rule and Suggests New Standars for Reimbursement of...

On July 19, 2013, CMS issued the proposed CY 2014 MPFS rule and suggested significant modifications to its regulations governing Medicare coverage of investigational devices and the routine items and services furnished to...more

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more

Industry Reacts to FDA Proposed Revisions to Acceptance of Data From Clinical Studies for Medical Devices

On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical studies in support of medical device applications. The FDA noted that current...more

Agencies Provide Guidance on Additional Health Care Reform Changes Impacting Non-Grandfathered Employer Group Health Plans

The Departments of Health and Human Services, Labor, and Treasury (collectively, the “Departments”) during the first half of the year issued guidance in the form of Frequently Asked Questions (the “FAQs”) on certain...more

Federal Circuit Clarifies Standards for a Clinical Trial to Be Public Use

In 2007, Dey L.P., Dey Inc., and their parent company Mylan, Inc. (collectively, "Dey") sued Sunovion Pharmaceutical, Inc. ("Sunovion"; formerly known as Sepracor, Inc.) for infringement of five of Dey's patents....more

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