Tag Archives: Clinical trials

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments. The purpose … Continue Reading

CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

On December 10, 2013, CMS published its final rule updating Medicare physician fee schedule (PFS) rates and polices for calendar year (CY) 2014, which includes a 20.1% across-the-board cut in PFS rates in 2014 (down from 24.4% projected under the proposed rule). The cuts are largely due to the statutory Sustainable Growth Rate (SGR) update formula, … Continue Reading

OIG Examines Clinical Trial Data and Safety Monitoring Boards

The OIG has issued a report entitled “Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues.” The report examines the effectiveness of data and safety monitoring boards (DSMB) – or committees of experts that provide ongoing reviews of clinical trial data to ensure the safety of study subjects and … Continue Reading

HHS Seeks Comments on IRB Assessment of Risks in Standard of Care Interventions Research; Aug. 28 Meeting Scheduled

The Department of Health and Human Services (HHS) is seeking input on how institutional review boards (IRBs) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects as part of … Continue Reading

Bioethics Panel Seeks Comments on Ethical/Legal Issues Involving “Incidental Findings” in Research and Testing

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by “incidental findings” (e.g., information obtained from testing that was not its intended or expected object) that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and … Continue Reading

FDA Issues New Draft Guidance Documents on Access to Investigational Drugs

On May 9, 2013, the Food and Drug Administration (“FDA”) announced the availability of two new draft guidance documents answering common questions on FDA’s implementation of regulations related to access to investigational drugs. The first draft guidance, entitled “Charging for Investigational Drugs Under an IND – Qs & As,” addresses FDA’s implementation of 21 C.F.R. … Continue Reading

FDA Issues New Guidance Documents

In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following: Financial Disclosure by Clinical Investigators. This final guidance … Continue Reading

FDA Releases Draft Guidance Documents on Providing Submissions in Electronic Format

The FDA released draft guidance on January 3, 2013 entitled Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications. The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act, which amended to Federal Food, Drug, and Cosmetic Act to … Continue Reading

FDA Draft Guidance Addresses Clinical Trial Enrichment

The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in NDAs … Continue Reading

FDA Issues Two Final Guidances on Safety Reporting Requirements

The FDA has released two final guidance documents intended to help sponsors and investigators comply with safety reporting requirements for IND applications and bioavailability (BA) and bioequivalence (BE) studies: Safety Reporting Requirements for INDs and BA/BE Studies, and Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide. Comments regarding both guidance … Continue Reading

FDA Issues Two New Draft Guidance Documents Related to the Conduct of Clinical Trials

The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to … Continue Reading

FDA Draft Guidance Document on Transferring Clinical Investigation Oversight to Another IRB

This post was written by Erin Janssen. The FDA has published a notice announcing the availability of draft guidance on “Considerations When Transferring Clinical Investigation Oversight to Another IRB.” This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is … Continue Reading

FDA Final Rule on Disqualification of Clinical Investigators

FDA recently published a final rule that expands the scope of clinical investigator disqualification. Under the rule, when the FDA determines that an investigator is ineligible to receive one kind of test article (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for … Continue Reading

FDA Public Hearing Regarding Regulation of Clinical Trials (April 23-24)

This post was written by Erin Janssen. FDA will conduct a 2-day public hearing on April 23 and 24, 2012 to obtain input from interested persons on FDA’s scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. Individuals who wish to attend or … Continue Reading

FDA Issues Guidance on New Informed Consent Requirements

This post was written by Erin A. Janssen. FDA has issued guidance in the form of a Small Entity Compliance Guide entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand new informed consent requirements. In the Federal Register … Continue Reading

FDA Issues Draft Guidance Regarding Evaluation of Sex Differences in Medical Device Clinical Studies

This post was written by Erin Janssen. The FDA recently issued draft guidance entitled “Evaluation of Sex Differences in Medical Device Clinical Studies,” which indicates FDA’s current view of the study and evaluation of sex-specific differences in medical device clinical trials to support marketing submissions and post-approval study. In particular, the focus is on addressing potential differences in … Continue Reading

CMS Solicits Comments on Coverage with Evidence Development Framework

CMS is seeking comments on its Medicare coverage with evidence development (CED) policy, under which CMS provides conditional Medicare coverage for an item while collecting clinical data. CMS is looking for feedback on the use of CED in national coverage determinations and its impact on Medicare and its beneficiaries. The input will be used to “to develop … Continue Reading

Draft FDA Guidance on Exculpatory Language in Informed Consent

This post was written by Erin Janssen and Areta Kupchyk. The HHS Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) are seeking comments on a joint draft document entitled “Guidance on Exculpatory Language in Informed Consent.” Among other things, the draft document: Provides guidance on the regulatory prohibition on the inclusion … Continue Reading

FDA Guidance on Reproductive and Developmental Toxicities

This post was written by Erin Janssen and Areta Kupchyk. On September 23, 2011, FDA released guidance entitled “Reproductive and Developmental Toxicities–Integrating Study Results to Assess Concerns.” The guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a finding of toxicity has been identified, but … Continue Reading

Comment Period Extended for Proposed Rule Regarding Human Subject Protections

This post was written by Erin Janssen. On September 1, 2011, HHS published a notice extending the comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects might be modernized and revised to be more effective. That ANPRM, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects … Continue Reading

FDA Issues Draft Guidance Proposing Risk Based Approach to Oversight of Clinical Investigations

This post was written by Erin Janssen. On August 29, 2011, the FDA released draft guidance entitled “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.” FDA published the draft guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and … Continue Reading

HHS Issues Final Financial Conflict-of-Interest Rules for Researchers

On August 25, 2011, HHS published a final rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. The final rule revises 1995 standards on this subject in order to “update enhance the objectivity and integrity of the research process” and … Continue Reading

FDA Issues Draft Guidance Regarding Design of Pivotal Clinical Investigations for Medical Devices

This post was written by Erin Janssen. The Food and Drug Administration (FDA) issued draft guidance on August 15, 2011 to help researchers and manufacturers design better quality clinical studies in support of premarket approval applications for certain medical devices. Although the public can comment on the draft guidance at any time, FDA has requested that … Continue Reading

FDA Announces Open Registration for Clinical Investigator Training Course

This post was written by Erin Janssen. The FDA has announced the opening of registration for its third annual FDA Clinical Investigator Training Course, co-sponsored by the FDA Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI). The course will be held on November 7-9, 2011 in Silver Spring, Maryland. Topics to be discussed … Continue Reading