COVID-19: CDC, FDA and CMS Guidance

This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.

The Food and Drug Administration reminded the public of the importance of receiving COVID-19 vaccines in accordance to their agency authorizations, a process that FDA said will safely provide the 鈥渞emarkable鈥 levels of protection observed during large, randomized clinical trials.
The Food and Drug Administration last month added to its device shortage list several device types, along with clarifying notes and resource links.
The Food and Drug Administration鈥檚 Vaccines and Related Biological Products Advisory Committee Dec. 17 recommended the approval of Moderna鈥檚 mRNA-1273 COVID-19 vaccine candidate.
The Centers for Medicare & Medicaid Services announced that it is extending the third quarter 2020 data submission deadlines for several of its quality reporting and value programs for hospitals, post-acute care and other providers.
Drug overdose deaths increased 18% over the 12-month period that ended in May to a record 81,230, according to a new Centers for Disease Control and Prevention advisory.
The Food and Drug Administration authorized a prescription BinaxNOW COVID-19 test for use by patients at home, in partnership with a telehealth service that will take users through the sample collection process and assist in reading and understanding the results.
The Food and Drug Administration Center for Biologics Evaluation and Research Prevention has addressed new information that shipped vials of Pfizer鈥檚 BND162b2 mRNA COVID-19 vaccine contain extra doses, indicating that it is acceptable to use every full dose obtainable from each product vial.
The Centers for Medicare & Medicaid Services (CMS) today announced that it is extending the quarter 3 (Q3) 2020 data submission deadlines for several of its quality reporting and value programs for hospitals, post-acute care and other providers. CMS indicates the extension is intended 鈥渢o help鈥
The Centers for Disease Control and Prevention will award states and territories another $227 million in funding from the Coronavirus Aid, Relief, and Economic Security Act and Paycheck Protection Program and Health Care Enhancement Act for COVID-19 vaccine preparedness and complementary activities鈥