Generics Bulletin 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

FDA Guides On COVID-19 Obstacles To ANDA Studies

Protecting Participants In Bioequivalence Studies Should Be Top Priority

Executive Summary

Specific guidance for ANDA sponsors on bioequivalence studies during the COVID-19 pandemic has been published by the US FDA.

You may also be interested in...



FDA Alert Curbs Enthusiasm For Hydroxychloroquine And Chloroquine

A drug safety communication published by the US FDA over hydroxychloroquine and chloroquine has cooled hopes that the drugs could be used as key treatments to address the coronavirus pandemic.

FDA Goes Straight To Final Guidance For Generic Chloroquine

Product-specific guidances for generic versions of chloroquine and hydroxychloroquine have been issued by the FDA. Final guidance for chloroquine has been published without a draft version due to the need for speedy action amid the COVID-19 outbreak.

FDA Scales Back Domestic Inspections Due To Coronavirus

After postponing foreign inspections, the US FDA has further decided to scale back domestic inspections due to the coronavirus outbreak.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB149853

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