Liminal BioSciences Inc. PFSCF

FDA changes under COVID19

[stockbuphoon]

FDA changes under COVID19

1. Face-to-face interactions with the FDA that were previously scheduled for March and April of this year have been or will be converted to teleconferences.

2. Review cycles and timelines for meetings to be granted may be delayed

3. Global health authorities are working in close partnership with industry and academia to quickly progress therapies, vaccines, and diagnostics for COVID-19.

4. Expect to see delays of on-site pre-approval manufacturing site inspections

5. The limitations of on-site pre-approval facility inspections extend to clinical and sponsor inspections.

6. With social distancing and travel bans, on-site GxP audits and vendor selection visits have already been impacted




 

https://www.lifescienceleader.com/doc/assessing-the-impact-of-covid-on-regulatory-interactions-inspections-audits-0001?vm_tId=2202027&user=367b4626-42c7-4298-ba22-10750205ae57&vm_alias=Assessing%20The%20Impact%20Of%20COVID-19%20On%20Regulatory%20Interactions,%20Inspections,%20And%20Audits&utm_source=mkt_LSL&utm_medium=email&utm_campaign=LSL_03-30-2020&utm_term=367b4626-42c7-4298-ba22-10750205ae57&utm_content=Assessing%20The%20Impact%20Of%20COVID-19%20On%20Regulatory%20Interactions,%20Inspections,%20And%20Audits&mkt_tok=eyJpIjoiWldNeE9EWmtNVEkxWkRBeCIsInQiOiJMSVVZYjBiU3hMTzdYRHdSTktYV3pxUlpCN3J4MHNMQzhOeVI0eXZRTllBMGg5amhaZkdoU3JIV3cyWStmN1p2R2ozTkZ5dVc1YkhDXC9CdE00OFpTU2VQMGhKTVJUTmlCdlQ1Zm9LcFpxbnE1eUxIY1NiNlNkWjdOMkZpQjFcL0lGIn0%3D