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

Conjugated estrogens

Executive Summary

FDA hopes to have revised guidance on in vivo bioequivalence studies for conjugated estrogens out by the end of the year. Draft was issued on June 16 ("The Pink Sheet" June 26, p. 5). However, FDA said issuance of revised guidance may be delayed if the agency decides document should be reviewed by Fertility and Maternal Health Drugs Advisory Committee, which is next scheduled to meet Feb. 1-2. Guidance was discussed at Oct. 20 meeting between FDA and Able Labs. Able said it is doing groundwork for in vivo bioequivalence studies and that FDA advised it to wait for the guidance before proceeding further. FDA previously had rejected Able's urinary excretion-based ANDA for estrogens.

You may also be interested in...



Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement

US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors

But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.

Finance Watch: A SPACtacular Week For Biopharma Deals And Dollars

Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.

UsernamePublicRestriction

Register

ID1131516

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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