News and information useful to Cleveland-Marshall College of Law students, faculty and staff.


Wealth of Information on FDA Coronavirus Disease 2019 Site

FDA logoThe U.S. Food and Drug Administration (FDA) Coronavirus Disease 2019 website provides a wealth of information for administrators, health care professionals and the general public.  The site includes FDA Emergency Use Authorizations, Guidance Documents & Policies, and “conservation strategies” for Personal Protective Equipment, as well as News Releases, information on how individuals who have fully recovered from COVID-19 may Donate COVID-19 Plasma and numerous Educational Resources.

FDA Holds Public Hearing & Opens Public Docket on Cannabis-Derived Compounds

graphic of CBD oilThe U.S. Food and Drug Administration (FDA) recently held a public hearing on cannabis-derived compounds, including cannabinoids, such as cannabidiol (CBD).  The hearing was prompted by industry confusion since the passage of the Agriculture Improvement Act of 2018 (AIA; Pub. L. No. 115-334).  The AIA excluded hemp from the statutory definition of marijuana (a controlled substance), and expanded the definition of hemp to “Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” [See The 2018 Farm Bill (P.L. 115-334): Summary and Side-by-Side Comparison, Congressional Research Service R45525, updated 2/22/19.]  The FDA continues to classify cannabis-derived compounds as “unsafe,” but the FDA has taken little action to remove such products from the marketplace.  The recent FDA public hearing provided a forum for “stakeholders to share their experiences and challenges with products containing cannabis and cannabis-derived compounds, including information and views related to the safety of such products, as well as to solicit input relevant to the agency’s regulatory strategy related to existing products.”  The FDA has also opened a public docket on regulations.gov, and the docket will be open until 7/16/19.  For additional information see the FDA Regulation of Cannabis and Cannabis-Derived Products page.

FDA CDRH Regulatory Science Priorities

FDALogo2The U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) recently released its Regulatory Science Priorities (FY 2016), which will “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace.”  This CDRH report will guide intramural research funding decisions, and serve as an aide for external stakeholders to target their resources to complement CDRH research activities.  Two of the top ten Regulatory Science Priorities are:  Leverage “Big Data” for regulatory decision making; and Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making.  “Big Data warehouses such as the human genome sequence database contain a wealth of scientific and clinical information relevant to the safety, performance and/or quality of medical devices.”  Such information “can potentially enhance the quality and effectiveness of regulatory decision making” as well as “aid the regulatory process by streamlining scientific review and identifying potential emerging post-market issues earlier in the process.”  For additional information, connect to the FDA – Medical Devices – Science & Research (Medical Devices) – Regulatory Science Priorities page.

New FDA Patient Engagement Advisory Committee

FDALogo2The U.S. Food and Drug Administration recently announced (80 Fed. Reg. 57007, 9/21/15) the creation of the Patient Engagement Advisory Committee (PEAC) to advise the agency “on complex issues relating to medical devices, regulation of devices, and their use by patients,” and will receive public comment on potential PEAC topics until 11/20/15.  The PEAC will be composed of nine voting members, including the chair, as well as temporary non-voting members selected for particular PEAC meeting topics.  The FDA Commissioner or designee will select the voting PEAC members envisioned to be experts in “clinical research, primary care patient experience, and health care needs of patient groups in the United States,” or “experienced in the work of patient and health professional organizations, methodologies for eliciting patient preferences, and strategies for communicating benefits, risks and clinical outcomes to patients and research subjects.”  The FDA is receiving nominations for PEAC nonvoting members from industry organizations until 10/21/15 (80 Fed. Reg. 57004), nominations for PEAC voting members from consumer organizations until 10/221/15 (80 Fed. Reg. 57002), and nominations for PEAC members from the general public until 11/20/15 (80 Fed. Reg. 57003).  For additional information, see the FDA Patient Engagement Advisory Committee page.