Generics Bulletin 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

US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

Executive Summary

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

You may also be interested in...



Pre-ANDA Meetings Proving Tough To Get – Nearly Half Of Requests Denied

During first half of fiscal 2018, US FDA only granted 16 of 31 pre-ANDA meeting requests, but said it was to ensure meetings were productive.

Allergan Performs Better Than Expected, But Still Conducting Strategic Review

Financials are holding up well despite generics launching against multiple Allergan products, but with stock price falling the company is conducting a strategic review to make sure it isn't missing out on any alternative business strategies that could boost the enterprise's value.

US FDA's Generic Research May Include EpiPen And Competitors

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC031354

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