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

ANDA Easily Correctable Deficiencies Focus On Quality

Executive Summary

FDA program allows generic sponsors to keep applications on track, but they must respond quickly with a well-formatted cover letter.

You may also be interested in...



Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.

US FDA User Fee Renewals Remain On Schedule Despite Coronavirus

Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.

US FDA And Sponsors Resolve Disclosure Issues On Complex Trial Design Pilot Projects

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

Topics

UsernamePublicRestriction

Register

PS056090

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