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Guidance variants

Variants Spur New FDA Guidance on COVID Vaccines, Tests, Drugs

Immunogenicity trials will test vaccines’ effectiveness so they can be tweaked or boosters given, should the virus variants show resistance. Medscape Medical News

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Guidance updates

FDA Updates Guidance on Ventilator Splitters, Cites Potential Risks

Although the FDA hasn’t received any adverse event reports related to ventilator splitters, it has updated guidance after recent publication of real-world challenges and risks associated with emergency use. News Alerts

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Guidance updates

AGA Updates Guidance on the Medical Management of Colonic Diverticulitis

(MedPage Today) — Study Authors: Anne F. Peery, Aasma Shaukat, Lisa L. Strate Target Audience and Goal Statement: Gastroenterologists, colorectal surgeons, radiologists The goal of the American Gastroenterological Association (AGA) expert review…

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Gives Guidance

FDA Gives Guidance on Allergy, Pregnancy Concerns for COVID Vaccine

Agency officials said Saturday the vaccine is safe for people with a history of any allergy, but not a history of severe reactions. Pregnancy concerns are less defined. Medscape Medical News