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

Can We Talk? US FDA Remote Records Review Missteps Worry Industry

Executive Summary

Alkermes CRL is just the latest fallout from black-hole process.

You may also be interested in...



What Congress Could Do About Remote US FDA Inspections That Are Not Inspections

Now that video site tours can sidestep pandemic travel restrictions, an expert who consults for industry on US FDA inspections suggests Congress may want to revise the FD&C Act to sidestep the “site entry” inspections limitation.

Remote Methods Drove Most US FDA Enforcement Actions In FY 2021

Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.

Alkermes CEO Appeals To US FDA’s Woodcock In ‘COVID-19 Pandemic And Depression’ Meeting

Richard Pops has publicly complained about the agency’s review performance during COVID, and Alkermes’ application for a mental health product appears to have been held up because of inspection issues.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143316

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