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February 12, 2021

In This Issue
MMA Weekly State Vaccination Plan Update
MMA Leadership & Staff Share Condolences on Passing of George Smith
Maine PMP to Stay with Appriss System
Next Maine CDC COVID-19 Update for Clinicians with Stephen Sears, MD scheduled for Feb 25
Federal Government Finalizes Purchase of 200M COVID-19 Vaccines Doses
US CDC: Fully Vaccinated Meeting Criteria No Longer Required to Quarantine After Exposure
AMA President: Physicians & Medical Societies Can Play Vital Role Advocating for Strong Public Health
NEJM: The FDA’s Experience with Covid-19 Antibody Tests
NEJM: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
Monoclonal Antibody Authorization from the FDA (Updated 02/09/21) & MaineCare Reimbursement
Guidance for Industry: Investigational COVID-19 Convalescent Plasma (Updated 02/11/20)
Maine Legislative Leadership COVID-19 Bill Set for Public Hearing Tuesday
Next MMA Legislative Call Will Be Wednesday, February 17th
Daniel Hanley Center for Health Leadership’s Renowned Physician Executive Leadership Institute – The Advanced Course Enrollment is OPEN
PPE Available Through the MMA & ActionPPE
A Message from Maine Responds: Volunteer Opportunity
MAINE LEGISLATURE
Maine Legislature Week 5 Update
Upcoming Public Hearings & Work Sessions; New Bills Introduced
UPCOMING EVENTS
Upcoming Specialty Society Meetings
Maine CDC Physicians To Host Regular Clinician COVID Vaccine Info Sessions
Suicide Prevention and Management in Healthcare Practice Settings: A Comprehensive Evidence-Based Approach
MOA VIRTUAL Midwinter Symposium - February 12th-14th
Maine CDC Annual Prevention Professionals Conference - March 2nd-3rd
AAP EQIPP Course: Immunizations - Strategies for Success (for RURAL Health Providers)
HEALTHCARE EMPLOYMENT OPPORTUNITIES
Physician (BC/BE in Family Medicine)
Nursing Director
Medical Director - Bucksport Regional Health Center
Rangeley Family Medicine seeks Physician

 
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Guidance for Industry: Investigational COVID-19 Convalescent Plasma (Updated 02/11/20)

On August 23, 2020, FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  The FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). 

For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND. 

Read the Final Guidance Document, issued on February 11, 2021. It supersedes the guidance issued on January 15, 2021. 

The public may submit either electronic or written comments on FDA guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the following way: 

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov  will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission. 

Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

 

 

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