Author:Nina Hintlian
Protecting the Nanotechnology Workforce: NIOSH Regulations
The Department of Health and Human Services, along with National Institute for Occupational Health and Safety and the Center for Disease Control have begun a concerted effort to fill the knowledge gaps in defining the hazards, exposures, and risks involved with handling nanomaterials. Investigators are working to provide guidance for those working in the field of nanotechnology to address the risks associated with working with animals exposed to various engineered nanomaterials, epidemiologic research, and exposure limits. The National Institute for Occupational Safety and Health has summarized its progress and recommended risk management strategies for those in the field.
Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988
The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies. The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.
Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations
The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A). In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.
Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments
The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules. The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework. The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).
FDA Guidance for Clinical Research Projects Using Expansion Cohorts in First-In-Human Clinical Trials to Expedite the Development of Oncology Drugs and Biologics
In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.