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FDA Roundup: February 11, 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. 11, the U.S. Food and Drug Administration (FDA) opened the application portal for accreditation bodies interested in participating in the Laboratory Accreditation for Analyses of Foods (LAAF) program. LAAF Application Portal Now Open | FDA Under the LAAF program, the FDA will recognize accreditation bodies that will accredit food testing laboratories to standards established in the final rule on Laboratory Accreditation for Analyses of Foods (referred to as LAAF-accredited laboratories).
- On Feb. 9, the FDA issued a draft guidance for industry, “Development of Non-Opioid Analgesics for Acute Pain,” to provide recommendations to companies developing non-opioid analgesics for pain lasting up to 30 days. This guidance fulfills certain requirements of section 3001(b) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, commonly referred to as the SUPPORT Act.
- On Feb. 9, the FDA released a guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry. The guidance is intended to help food producers and processors who handle foods that may contain residues of the pesticide chemical chlorpyrifos. The Environmental Protection Agency (EPA) published a final rule on Aug. 30, 2021, revoking all tolerances for chlorpyrifos; these tolerances are set to expire on Feb. 28, 2022.
- On Feb. 7, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
- COVID-19 testing updates:
- As of today, 421tests 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 70 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, 15 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 10 molecular tests for serial screening programs. The FDA has also authorized 818 revisions to EUA authorizations.
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