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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Oral Contraceptives Labeling Guidance Removes Mention Of Emergency Use

This article was originally published in The Pink Sheet Daily

Executive Summary

First draft of guidance listed dosing regimens appropriate for emergency use; PhRMA questioned inclusion of the information in earlier comments.

You may also be interested in...



FDA Oral Contraceptives Guidance "Oversimplifies" Risk Information, J&J Says

Johnson & Johnson is concerned that the draft guidance will not "objectively relate the risks" to physicians. The company also recommends including newer references for risk information.

US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot

ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.

Topics

UsernamePublicRestriction

Register

PS012935

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