Note: This is Part 2 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity. Part 1, covering the Digital Health Technologies framework is available here.

The Food and Drug Administration (FDA) has released draft guidance intended to help modernize the design and conduct of clinical trials by making them more efficient and enabling them to incorporate the newest technological and methodological advancements into their design.

FDA continues to issue guidance in the wake of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which in part requires FDA to provide further oversight and guidance on “Clinical Trial Diversity and Modernization.” Under Section 3607(c) of FDORA, consistent with its obligations modernize clinical trials, FDA is specifically required to “work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation” as it pertains to innovative approaches to clinical trial design and implementation.Continue Reading FDA Issues Draft Guidance on Good Clinical Practice in Ongoing Clinical Trial Modernization Efforts

Note: This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity.

The Food and Drug Omnibus Reform Act of 2022 (FDORA) signed by President Biden on December 29, 2022, introduced significant changes to the way in which FDA will provide oversight for clinical trials as it pertains to “Clinical Trial Diversity and Modernization.” Under FDORA, among other things, FDA is required to issue guidance on decentralized clinical trials (which is a clinical trial in which some or all trial-related activities occur at a location separate from the investigator’s location) and to provide clarification on the use of digital health technologies (DHTs) in clinical trials.

Prior to the passage of FDORA, FDA set its sights on DHTs in the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, acknowledging the increased use of DHTs in drug development and the need for appropriate internal expertise and external guidance for their use and evaluation.Continue Reading New Opportunities, New Challenges: FDA Elaborates on use of Digital Health in Drug and Biological Product Development

In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy.

The OIG indicated it would not impose administrative sanctions, despite the fact

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on ClinicalTrials.gov. The rule is intended to clarify as well as establish additional procedures and requirements for submitting: (i) registration, (ii) summary results, and (iii) adverse event information for such applicable clinical trials.

According to NIH, the expanded registry and results data bank will “help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research.”  Among other things, the final rule:
Continue Reading NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President.  The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s (DEA) process for

On October 7, 2015, President Obama signed into law H.R. 1624, which amends the Affordable Care Act’s (ACA) definition of “small employer” by maintaining the definition of a small group market as 1-50 employees and thus reducing the number of employers covered by certain new health insurance coverage requirements set to go into effect

On September 28, 2015, the House of Representatives approved by voice vote S. 139, the Ensuring Access to Clinical Trials Act. This legislation would allow individuals to participate in clinical trials for rare diseases without counting the income earned from these trials against their eligibility for Medicaid and Supplemental Security Income. The legislation, which

Two Congressional committees are holding hearings this week on health policy issues.  First, the Senate Health, Education, Labor and Pensions (HELP) Committee has scheduled a September 16, 2015 hearing on “Achieving the Promise of Health Information Technology: Improving Care Through Patient Access to Their Records.”   The HELP Committee also will hold a September 17 hearing on “Biosimilar Implementation: A Progress Report from FDA.” Second, on September 18 the House Energy and Commerce Health Subcommittee will examine four Medicaid bills:
Continue Reading Congressional Hearings to Focus on Health IT, Biosimilars, Medicaid Program Legislation

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 Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exemptions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include:
Continue Reading Agencies Release Proposed Overhaul of the Common Rule

Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars.

As discussed on our Life Sciences Legal Update blog, the FDA has released draft guidance clarifying its acceptance of medical device clinical data from studies conducted outside of the United States. The draft guidance highlights special considerations that apply when using foreign clinical data, including applicability to populations within the US, and provides recommendations

As discussed on our sister blog, Life Sciences Legal Update, the FDA has published a notice soliciting comments on a draft guidance document on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products.  The HHS Office for Human Research Protections (OHRP) also is considering

On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the

NIH has just released a proposed rule that would clarify and expand requirements for the submission of clinical trial registration and results information, including adverse event information, to the ClinicalTrials.gov database in conformance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). The rule would implement the statutory requirement for the submission of

On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks