Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA To Train Investigators On mRNA Vaccine Manufacturing

Executive Summary

Agency seeks bids to train biologics field personnel on relevant aspects of mRNA technology such as corralling stray plasmids or nanoparticles as the possibilities for the technology expand in the wake of the Pfizer/BioNTech and Moderna COVID-19 vaccine successes. Review documents suggest the first mRNA vaccine inspections focused on more traditional issues.

You may also be interested in...



US COVID-19 Relief Law Boosts Pharmaceutical Manufacturing Programs; Is More To Come?

$10bn here and $6bn there on top of what’s left from earlier CARES Act gives government more options on COVID-19 medical countermeasures.

US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act

Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Topics

Related Companies

UsernamePublicRestriction

Register

PS146119

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel