Policy Updates

6/14/22 — The CDC issued a Health Alert Network (HAN) Health Update to alert clinicians to clinical presentations of monkeypox seen so far in the United States and to provide updated and expanded case definitions intended to encourage testing for monkeypox among persons presenting for care with relevant history, signs, and symptoms. Since May 2022, … Continued

6/14/22 — The FDA issued an emergency use authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. The SARS-CoV-2 virus has mutated over time resulting in genetic variation in circulating virus strains, also called lineages. The Labcorp VirSeq SARS-CoV-2 NGS Test is:  The first COVID-19 test … Continued

6/8/22 — Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast and mold and may contain the bacteria Bacillus cereus. Read the FDA safety alert.

6/7/22 — The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. The FDA is working actively … Continued

6/7/22 — The FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19.  Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this … Continued

5/25/22 — The FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.

5/25/22 — The FDA issued warning letters to Santhigram Kerala Ayurvedic Co. of U.S., Inc.  and to Ayuryoga, Inc. for selling unapproved products with fraudulent claims to treat multiple diseases, including COVID-19. 

5/25/22 — The FDA revised the scope of authorization for Evusheld’s EUA to include new information on hypersensitivity reactions and the risk of cross-hypersensitivity with COVID-19 vaccines and related clinical recommendations. Clinicians should consider consulting an allergist-immunologist prior to administering Evusheld to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to a COVID-19 vaccine.  

5/24/22 — Following FDA’s revised EUA to include booster shots of the Pfizer-BioNTech COVID-19 vaccine to children five years of age and older, the CDC strengthened its COVID-19 recommendation to include a booster shot for this age group five months after their initial Pfizer vaccination series. Read the CDC announcement.