Clinical Trials

News & Analysis as of

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2015.

EPA Releases TSCA Work Plan Chemical Problem Formulation, Initial Assessment For 1,4-Dioxane: On April 28, 2015, the U.S. Environmental Protection Agency (EPA) released the Toxic Substances Control Act (TSCA) Work Plan...more

New state law allows access to investigational drugs

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more

Decision Highlights Questions Over Substantiation for Weight Loss Claims

The Eleventh Circuit recently issued a decision in an contempt proceeding against Hi-Tech Pharmaceuticals and several individuals. The case highlights the ongoing debate over whether clinical trials are required for weight...more

Health Care Update - May 2015

In This Issue: - House Energy and Commerce Continues 21st Century Cures Progress - Pioneer ACO Program to be Expanded - Federal Regulatory Initiatives - Congressional Initiatives - Other Health Care...more

Also In The News - Health Headlines - April 2015 #4

CMS Announces Round 1 2017 DMEPOS Competitive Bidding System – On April 21, 2015, CMS announced plans for a new bidding process for the supplier contracts awarded in the Round 1 Recompete of the DMEPOS Competitive Bidding...more

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

Today the bipartisan leadership of the House Energy and Commerce Committee released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development, and delivery of...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

New Smartphone Software Provides Groundbreaking Opportunity for Medical Research

Smartphone applications ("app") are saturating the health care world in numerous and various ways. There is an app to track your sleep, one to track your heart rate, one to track steps and even one to measure your blood...more

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

Health Update - March 2015

Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report - Editor’s note: As Affordable Care Act (ACA) implementation moves forward and the marketplace continues to evolve, there is a...more

Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

Pomegranate Health Benefit Claims Were False, Misleading - POM Wonderful, LLC, et al. v. Federal Trade Commission

In an opinion addressing the amount and type of scientific evidence required to substantiate disease treatment and prevention claims, the U.S. Court of Appeals for the District of Columbia upheld the Federal Trade...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Lengthy Clinical Trial Process Gets Overhaul by FDA

Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities....more

POM Wonderful Inc. v. FTC: Lessons Learned

On January 30, 2015, the United States Court of Appeals for the District of Columbia issued an opinion in a case regarding the Federal Trade Commission’s (FTC) challenge to the advertisements of POM Wonderful’s (“POM”)...more

Clinical Trial and Medicare Provider Quality Improvement Provisions in House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“Committee”) released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting...more

European Clinical Trial Regulations Public Consultation – Confidentiality Concerns

Clinical Trial Regulations - On 21 January 2015, the European Medicines Agency (EMA) began a public consultation on the new European Clinical Trial Regulations (CTRs)....more

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more

China Announces Revised Good Clinical Practices for Public Comments

The China Food and Drug Administration (“CFDA”) recently released its proposed revisions to Good Clinical Practices (“GCP”) for pharmaceutical clinical studies for public comments. The proposed revisions, if eventually...more

Also In The News - Health Headlines - February 2015

House Committee Releases 21st Century Cures Discussion Document – On January 27, 2015, the U.S. House of Representatives Energy and Commerce Committee released a discussion document as part of its 21st Century Cures...more

FTC Tastes “Sweet” Victory: The Implications of POM Wonderful for Government Practice

In part two of this two-part series, we explore two critical takeaways for those facing potential government intervention: (1) the implications of the Court’s deference to the Commission, and (2) whether a substantive...more

Clinical Trial Data: Shared Resource or Private Property?

In a recently released report titled “Sharing Clinical Data – Maximizing Benefits, Minimizing Risks,” the U.S. Institute of Medicine (IOM) has called for more clinical trial data transparency. Historically, participant-level...more

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