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
UsernamePublicRestriction

Before The Freeze: US FDA Inspection Data Pointed To Continued Foreign Facility Focus

Executive Summary

Until the coronavirus forced it to stop, the FDA had planned to up domestic and foreign inspections in FY 2020 and FY 2021, as the longer-term trend showed domestic inspections dropping and foreign inspections rising.

You may also be interested in...



US FDA’s Human Drugs Program Suffers In Adjustment Of Agency Priorities

President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.

Mutual Recognition's Next Evolution May Be Sharing Info On India And China Inspections

Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.

US Reliance On EU Drug Facility Inspections Begins In November

FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.

Topics

UsernamePublicRestriction

Register

SC081785

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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