HBW Insight 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

OTC Monograph Stakeholders Seek Confidentiality Assurances Ahead Of OMOR Meetings With FDA

Executive Summary

Judging by January draft guidance from the US FDA, the agency may feel compelled to make public any information a party submits in the context of a meeting to discuss data needs for an OTC monograph change. And special sunscreen considerations included in the CARES Act, which overhauled the FDA's OTC drug review program, aren't mentioned in the guidance, trade groups say.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS152465

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