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


FDA Moving Beyond Animal Rule To Animal Guidance With November Workshop

This article was originally published in The Pink Sheet Daily

Executive Summary

Focus will be on addressing regulatory challenges faced in developing countermeasures to chemical, biological and radiological threats.

You may also be interested in...

GSK’s Anthrax Treatment Raxibacumab Gets Second Chance To Be First Animal Rule NME

FDA’s Anti-Infective Drugs Advisory Committee will have new pharmacokinetic data to review when it meets Nov. 2 to discuss the monoclonal antibody, which targets the anthrax toxin rather than the pathogen.

Smallpox Treatments: Are Monkeypox Or Mousepox Acceptable Substitutes For Studying The Virus?

Smallpox has been eradicated for more than 30 years, but FDA isn't sure whether sponsors studying treatments in animals in case terrorists deliberately infected people can use substitute pathogens under the “Animal Rule.” The Antiviral Drugs Advisory Committee will weigh in on the issue.

Animal Rule's Study Designs For Anthrax Vaccine Show Utility For Other Products

When an FDA advisory panel gave its enthusiastic backing to the strategy for anthrax vaccine research developed by the agency's Center for Biologics Evaluation and Research, it also provided an important precedent for future applications of the "animal rule," which allows sponsors to conduct animal trials when human clinical trials would be impractical or unethical.

Related Content





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