Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Exit Interview: US FDA’s Sandra Kweder Reflects On A 30-Year Career As She Heads Into Retirement

Executive Summary

Having recently returned from six years overseas as the FDA’s liaison to the European Medicines Agency, ‘now was a good time to try something different,’ Kweder says in a Pink Sheet interview. Her tenure at the agency included numerous leadership roles in CDER as well as spearheading the development of the pregnancy labeling rule.

You may also be interested in...



US FDA's Brexit: One Staffer Moving, But Impact Still May Loom Large

Uncertainty about Brexit's impact on the FDA-EMA mutual recognition agreement are among issues worrying regulators as countdown continues to the UK's departure from the EU.

Pregnancy Labeling Gets A New Look

FDA’s final rule includes narrative summaries of risk information about use during pregnancy and lactation, and it creates a new section relevant to drug effects on reproductive potential.

Pregnancy Labeling Changes May Spur Research, FDA Says

Final regulation eliminates use of letter-based categories to designate level of risk during pregnancy and lactation; in a change from the 2008 proposed rule, information relevant to drug effects on reproductive potential will now be housed in dedicated section.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147333

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