Generics Bulletin 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

FDA Guides On Bioequivalence Studies And COVID-19

Offers Advice On Protecting Participants In Studies For ANDAs

Executive Summary

Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.

You may also be interested in...



ANDA Submissions Drop To Start FY2021

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Aspen Expects Growth Following Sandoz And Viatris Deals

Aspen expects to report significant growth in its continuing operations for the first half of its financial year, following deals with Sandoz and Viatris that have seen the South African firm divest major businesses in Japan and Europe.

Three Pillars Must Support Value Added Medicines In EU

Medicines for Europe has called for fresh efforts to bolster the value added medicines sector and “level the playing field” with the US and its 505(b)(2) pathway, launching a new report setting out the three key areas in which greater EU action is needed.

Topics

UsernamePublicRestriction

Register

LL1132098

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