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


Docket Open For OTC Oral Phenylephrine GRASE Meeting, And So Is NDAC Consumer Member Seat

Executive Summary

Docket opened for 11-12 September NDAC meeting to consider oral phenylephrine GRASE data available since the agency last examined the ingredient. FDA also accepting nominations for individuals or representatives of consumer organizations for vacancies in voting or non-voting seats across its drug and medical technology advisory committees.

You may also be interested in...

US OTC Oral Phenylephrine GRASE Meeting Stretched To Two Days In Rescheduled NDAC

Nonprescription Drugs Advisory Committee will meet online 11-12 September to consider data regarding generally recognized as safe and effective status for oral phenylephrine as a nasal decongestant which have become available since FDA last examined ingredient.

US FDA Looks To Assure Advisory Committees' Subject Expertise With More Temporary Members

Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.

Advisory Panel Members On Unanimous Vote Recommending US FDA Approve OTC Birth Control

NDAC and ORUDAC members acknowledged the FDA’s concerns about some data provided by Opill sponsor HRA Pharma to support its OTC switch application. However, a greater share noted the “historic nature” of the proposal and the broad support expressed in the meeting’s public comment portion.

Related Content


Latest Headlines
See All



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