Generics Bulletin 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

FDA Releases Latest Product-Specific Guidances

Of 36 PSGs, 22 Are New And 14 Newly-Revised

Executive Summary

The latest tranche of product-specific guidances for generic development has been published by the US FDA.

You may also be interested in...



Genfit’s Post-NASH Plans Center On ACLF, Cholestatic Liver Disease

After last year’s Phase III failure in NASH, Genfit sees big opportunity in acute on chronic liver failure (ACLF), potentially with antiviral NTX. Its ongoing Phase III program in PBC as also is a potential revenue-driver.

AAM Laments Price Negotiation Legislation Passing US Senate

The AAM has criticized the passage of the US Inflation Reduction Act though the country’s Senate, claiming that the legislation’s “flawed framework for government price setting” will chill generic and biosimilar development and will reduce patient access.

Mayne And Mithra Obtain Long-Awaited NuvaRing Nod From FDA

Following a trio of complete response letters received since late 2018, Mayne Pharma and partner Mithra Pharmaceuticals have finally obtained US FDA approval for a generic version of Organon’s NuvaRing vaginal hormonal contraceptive ring.

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB150783

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