Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA issued a final guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” This guidance provides the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds. The agency is committed to supporting robust scientific research into understanding therapeutic uses and safety of cannabis products. The FDA believes the drug development and approval process represents the best way to ensure safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.
- On Monday, the FDA reopened the comment period for 45 days for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that appeared in the Federal Register on November 2, 2022. The FDA is reopening the comment period in response to a recent request from stakeholders to allow additional time for interested persons to develop and submit comments.
- On Monday, the FDA cleared for marketing the Tidepool Loop, a mobile application intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons six years of age and older. The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired. The Tidepool app is a prescription-only device for single patient use that works with integrated continuous glucose monitors (iCGMs) and alternate controller enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose (sugar) values. The app can also recommend, and with the user’s confirmation, control the delivery of correction insulin amounts when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop’s algorithm technology is designed to be compatible with other individual interoperable devices that meet pre-specified acceptance criteria set forth in a validation and integration plan provided by the sponsor and cleared by the FDA as part of the premarket submission.
- COVID-19 testing updates:
- As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
- The FDA has authorized 44 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1217 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.