Thanks for finding that Albert (which seemed reall
Post# of 36563
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Posted On: 07/27/2020 1:01:35 PM
Thanks for finding that Albert (which seemed really easy for you to find), I tried searching on the FDA site and could not locate this page.
My point is that this is a covid related IND which the FDA is focusing on, so I would think they would accommodate a teleconference rather than a 30 day written response.
Q4. Will some PDUFA and BsUFA applications be delayed because of the COVID-19
public health emergency?
A4. The New Drugs Program in CDER, and the Biologics Program in CBER are experiencing
considerable increases in COVID-19 related work, requiring shifting of staff resources to help
with these activities. The COVID-19 public health emergency also has other effects on our
resources such as deployments of staff who are members of the U.S. Public Health Service
Commissioned Corps. With many staff members working on COVID-19 activities, it is possible
that we will not be able to sustain our current performance level in meeting goal dates
indefinitely. We anticipate that the New Drugs Program and the Biologics Program may need to
allocate resources to focus on certain activities. We intend to focus resources on investigational
new drug applications (INDs), new drug applications (NDAs), and biologics license applications
(BLAs) (both 351(a) and 351(k) applications) for drugs or biologics related to COVID-19 or
certain other life-threatening conditions. Exceptions include the initial IND 30-day safety review
and other important safety issues that may emerge during IND development. We will continue to
work directly with the sponsors and applicants regarding their pending applications.
My point is that this is a covid related IND which the FDA is focusing on, so I would think they would accommodate a teleconference rather than a 30 day written response.
Q4. Will some PDUFA and BsUFA applications be delayed because of the COVID-19
public health emergency?
A4. The New Drugs Program in CDER, and the Biologics Program in CBER are experiencing
considerable increases in COVID-19 related work, requiring shifting of staff resources to help
with these activities. The COVID-19 public health emergency also has other effects on our
resources such as deployments of staff who are members of the U.S. Public Health Service
Commissioned Corps. With many staff members working on COVID-19 activities, it is possible
that we will not be able to sustain our current performance level in meeting goal dates
indefinitely. We anticipate that the New Drugs Program and the Biologics Program may need to
allocate resources to focus on certain activities. We intend to focus resources on investigational
new drug applications (INDs), new drug applications (NDAs), and biologics license applications
(BLAs) (both 351(a) and 351(k) applications) for drugs or biologics related to COVID-19 or
certain other life-threatening conditions. Exceptions include the initial IND 30-day safety review
and other important safety issues that may emerge during IND development. We will continue to
work directly with the sponsors and applicants regarding their pending applications.
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Disclaimer: Of course, all of this is my opinion and you should not make any investment decisions based on my opinion. I have not received any non-public information.