Provision Consulting GroupApr 29, 20222 minFDA NewsFDA approves new drug to improve heart function in adults with rare heart conditionApr 29 2022 FDA has approved Camzyos (mavacamten) capsules to treat adults with symptomatic New York Heart Association (NYHA)External...
Provision Consulting GroupApr 28, 20225 minFDA RegulationsAt-Home COVID-19 Diagnostic Tests Q&AApr 28 2022 At-home COVID-19 tests safety FDA authorized at-home COVID-19 tests are safe to use when people follow the manufacturer’s...
Provision Consulting GroupApr 27, 20222 minFDA NewsFDA Approves First COVID-19 Treatment for Young ChildrenApr 27 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include...
Provision Consulting GroupApr 20, 20228 minFDA RegulationsFDA, OTC Medical Devices Q&A for Device ManufacturersApr 20 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these...
Provision Consulting GroupApr 19, 20223 minFDA RegulationsFDA, OTC skin lightening productsApr 19 2022 FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing...
Provision Consulting GroupApr 14, 20222 minFDA NewsFDA Authorizes First COVID-19 Diagnostic Test Using Breath SamplesApr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...