|
FDA Roundup: February 4, 2022
Dear International Colleague,
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Feb. 3, the FDA issued a revised draft guidance for industry “Assessment of Pressor Effects of Drugs.” This draft guidance advises sponsors on the premarketing assessment of a drug’s effect on blood pressure. Because elevated blood pressure can increase the risk of stroke, heart attack and death, a drug’s effect on blood pressure is important to consider in risk assessment and product labeling. This draft guidance revises an earlier draft guidance that the agency issued in May 2018.
- On Feb. 3, the FDA’s Center for Devices and Radiological Health (CDRH) announced its 2022-2025 Strategic Priorities focusing on three priority areas. The center established clear goals and measures of success for the overarching device program and each strategic priority. CDRH’s measures of success will show the center’s progress toward its commitment to the American people that patients have access to high-quality, safe and effective medical devices.
- On Feb. 3, the FDA announced the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers to improve the security of the drug supply chain and add additional safeguards to protect patients from receiving harmful drugs. The proposed national standards, when finalized and in effect, will provide greater assurance that wholesale drug distributors and third-party logistics providers are sufficiently vetted and qualified to distribute prescription drugs. This proposed rule is an important part of the Drug Supply Chain Security Act
- On Feb. 2, the Center for Veterinary Medicine’s (CVM) Office of Research launched a new website to showcase its innovative research to protect human and animal health. Among new features, the Our Regulatory Research in Action page highlights stories illustrating how CVM’s regulatory research has immediate impact on human and animal health. The How We Innovate and Advance Emerging Technologies, Including 3Rs Research page describes advances that may impact human and animal health in the future. This website will also highlight efforts to replace, reduce and refine (i.e., the “3R’s”) the use of animals in research.
- On Feb. 2, the FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country.
In late Dec. 2021, the agency had previously announced temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.
In addition to the resumption of planning and conducting domestic surveillance inspections on Feb. 7, the FDA continues to conduct both foreign and domestic mission-critical inspections, as well as provide effective oversight of foods, drugs, medical products and tobacco leveraging a variety of tools, including remote assessments.
The agency also continues to proceed with previously planned foreign surveillance inspections that have received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation. Planning for additional foreign surveillance inspections is ongoing, with an anticipated goal of conducting foreign prioritized inspections starting in April.
Throughout all these activities, the agency remains committed to the health and safety of its investigators and will provide the protection needed to safely inspect facilities and conduct investigations at the ports and in agency laboratories.
The FDA also is continuing remote foreign supplier verification program activities for human and animal foods. Additionally, state inspections under the FDA contract have the discretion to make inspection decisions based on their local information.
- COVID-19 testing updates:
- As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 69 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, three EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 26 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 806 revisions to EUA authorizations.
|
