02/11/2022 Bebtelovimab (674KB) (reissued August 5, 2022) Show
Letter Granting EUA Amendment (March 30, 2022) (216KB) ASPR and FDA Statement on Shelf-Life Extension of Bebtelovimab (May 20, 2022) Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.Bebtelovimab is currently authorized in all U.S. regions until further notice by the Agency. Healthcare Providers (440KB) (updated August 5, 2022) Patients, Parents, and Caregivers (150KB)
Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab (225KB) CDER Scientific Review Documents Supporting EUA
Lagevrio (molnupiravir) (923KB) (reissued August 5, 2022) Lagevrio is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.Healthcare Providers (1.5MB) (updated August 5, 2022)
Patients, Parents, and Caregivers (131KB)
COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR) Dear Healthcare Provider Letter (268KB) Frequently Asked Questions on the Emergency Use Authorization of Lagevrio (1.01MB) Prescriber Checklist for Lagevrio (180KB) CDER Scientific Review Documents Supporting EUA
Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) (925KB) (reissued March 17, 2022, April 14, 2022, July 6, 2022, and August 5, 2022) Letter Granting EUA Amendment (March 18, 2022) (161KB) FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations (July 6, 2022) Extended Expiry Dating for Certain Paxlovid Lots (July 26, 2022) Healthcare Providers (1.67MB) (updated July 6, 2022) Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (1.22MB) (updated July 18, 2022) Patients, Parents, and Caregivers (1.11MB) (updated August 5, 2022)
COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR) Dear Healthcare Provider Letter (593KB) (updated August 5, 2022) Important Dispensing Information for Patients with Moderate Renal Impairment (476KB) Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (994KB) (updated July 6, 2022) CDER Conversation on Paxlovid for Health Care Providers CDER Scientific Review Documents Supporting EUA
Evusheld (tixagevimab co-packaged with cilgavimab) (293KB) (reissued December 20, 2021, February 24, 2022, and May 17, 2022) FDA authorizes revisions to Evusheld dosing (updated June 29, 2022) ASPR and FDA Statement on Shelf-Life Extension of Evusheld (June 28, 2022) Letter Granting EUA Amendment (June 29, 2022) (168KB) For emergency use as pre-exposure prophylaxis for prevention of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):
Healthcare Providers (1.6MB) (updated June 29, 2022)
Patients, Parents, and Caregivers (425KB) (updated June 29, 2022)
Dear Healthcare Provider Letter (439KB) (June 29, 2022)
Dear Healthcare Provider Letter (226KB) (May 17, 2022) Dear Healthcare Provider Letter (144KB) (March 22, 2022)
Frequently Asked Questions on the Emergency Use Authorization for Evusheld (919KB) (updated June 29, 2022) CDER Scientific Review Documents Supporting EUA
Healthcare Providers (231KB) Patients, Parents, and Caregivers (47KB) Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (128KB) CDER Scientific Review Documents Supporting EUA
Sotrovimab (375KB) (reissued October 8, 2021, December 16, 2021 and February 23, 2022) Letter Granting EUA Amendment (December 22, 2021) (161KB) ASPR and FDA Statement on Shelf-Life Extension of Sotrovimab (August 3, 2022) Important updates about sotrovimab (ASPR) For the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Due to the high frequency of the Omicron BA.2 sub-variant, sotrovimab is not currently authorized in any U.S. region. Therefore, sotrovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Healthcare Providers (1.38MB) (updated March 25, 2022)
Patients, Parents, and Caregivers (385KB) (updated March 25, 2022)
Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (257KB) (updated March 25, 2022) CDER Scientific Review Documents Supporting EUA
Propofol‐Lipuro 1% (344KB) Letter Granting EUA Amendment (December 16, 2021) (188KB) To maintain sedation via continuous infusion in patients greater than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting. 2Healthcare Providers (446KB) Patients, Parents, and Caregivers (190KB)
Bamlanivimab and Etesevimab (900KB) (Reissued February 25, 2021, August 27, 2021, September 16, 2021, December 3, 2021, December 22, 2021 and January 24, 2022) ASPR and FDA Statement on Shelf-Life Extension of Bamlanivimab and Etesevimab (May 4, 2022) Important updates about bamlanivimab/etesevimab (ASPR) Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Healthcare Providers (1.75MB) (updated January 24, 2022) Patients, Parents, and Caregivers (157KB) (updated December 3, 2021)
Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (312KB) (updated January 31, 2022) CDER Scientific Review Documents Supporting EUA
REGEN-COV (Casirivimab and Imdevimab) (1.03MB) (Reissued February 3, 2021, February 25, 2021, June 3, 2021, July 30, 2021, September 9, 2021, November 17, 2021 and January 24, 2022) ASPR and FDA Statement on Shelf-Life Extension of REGEN-COV (June 27, 2022) Due to the high frequency of the Omicron variant, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Healthcare Providers (1.74MB) (updated January 24, 2022)
Patients, Parents, and Caregivers (147KB) (updated July 30, 2021)
Dear Healthcare Provider Letter (435KB) (updated September 16, 2021) Statement on Post-Exposure Prophylaxis (July 30, 2021) Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated January 31, 2022) CDER Scientific Review Documents Supporting EUA Quick Reference Guide for Co-Packaged REGEN-COV (38KB) (September 16, 2021)
For emergency use by healthcare providers for the treatment COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). On May 10, 2022, Olumiant was approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Healthcare Providers (Updated May 10, 2022) (272KB) Patients, Parents, and Caregivers (Updated May 10, 2022) (128KB) Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) for Treatment COVID-19 (270KB) (Updated May 10, 2022) CDER Scientific Review Documents Supporting EUA
COVID-19 convalescent plasma (365KB) (Reissued February 23, 2021, March 9, 2021 and December 28, 2021) Letter Granting EUA Amendment (June 2, 2021) (107KB) Letter Granting EUA Amendment (February 9, 2022) (26KB) COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.Healthcare Providers (Updated December 28, 2021) (192KB) Patients and Parents/ Caregivers (Updated December 28, 2021) (151KB) Decision Memorandum (166KB) Decision Memorandum (December 27, 2021) (242KB)
Patients and Caregivers (52KB) REGIOCIT package insert for EUA (140KB)
[also listed under Medical Device EUAs] To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic. Healthcare Providers (135KB) Patients (125KB) Instructions for Use, Bloodline/ Tubing (83KB) Instructions for Use, UltraFlux (147KB) Instructions for Use, multiFiltratePRO (15.07MB) Summary of Product Characteristics (SmPC) (308KB) Instructions for Use, MultiPlus (110KB)
At which of the following time should the medical administrative assistant obtain pre authorization for a diagnostic procedure?Practice flashcards for exam. Which of the following should a medical administrative assistant explain to new patients prior to initial visit?Which of the following should a medical administrative assistant explain to new patients prior to an initial visit? The procedure to cancel an appointment.
Which of the following should a medical administrative assistant consult to find the proper method of scheduling an appointment for a particular office?Which should a medical administrative assistant consult to find the proper method of scheduling an appointment for a particular office? Practice policy manual. Each practice desihnates its preferred scheduling procedures in a policy and procedure manual.
Which of the following is the most efficient method for a medical administrative assistant to collect payment for services?What is the most efficient method for a medical administrative assistant to collect payment for services. Collect due amount at the time of the patient's visit -most efficient way to collect payment for services because it does not add unnecessary time.
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Which of the following is a medical administrative assistant required to obtain before providing a patients protected health information to authorize recipients?
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