Newsletter - October 29, 2020
The October Surprise? Covid Vaccines Will Not Be Expedited by an EUA - Dr. Peter Marks, FDA
The data needed to support an EUA will be almost identical to that required for a BLA for the Covid vaccines being developed, according to Dr. Peter Marks, Director of CBER, FDA. This is a major shift (read “clarification”) from the public perception of when Covid vaccines may be available in the US.n....Read More
FDA Does Not Regulate Telemedicine or Intends to
As telemedicine and virtual care increasingly become the norm for most patient-doctor interactions, FDA does not have any rules or standards for it. FDA treats telemedicine as similar to videoconferencing or teleconferencing interactions between patients and their providers, and as such does not intend to regulate the tools used for telemedicine.....Read More
The October Surprise? Covid Vaccines Will Not Be Expedited by an EUA - Dr. Peter Marks, FDA
The data needed to support an EUA will be almost identical to that required for a BLA for the Covid vaccines being developed, according to Dr. Peter Marks, Director of CBER, FDA. This is a major shift (read “clarification”) from the public perception of when Covid vaccines may be available in the US.n....Read More
FDA Does Not Regulate Telemedicine or Intends to
As telemedicine and virtual care increasingly become the norm for most patient-doctor interactions, FDA does not have any rules or standards for it. FDA treats telemedicine as similar to videoconferencing or teleconferencing interactions between patients and their providers, and as such does not intend to regulate the tools used for telemedicine.....Read More
