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 Outlines How Generic Drug Makers Can Reverse Filing Decisions

Executive Summary

ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.

You may also be interested in...



FDA Officials Cite Reasons For Denying Application Reviews Over Data Integrity Breaches

Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.

US FDA Adds Hand Sanitizer Import Alert Category After COVID-19 Production Surge Turned Deadly

Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.

Deadly COVID-19 Hand Sanitizer Production Surge Prompted US FDA's New Import Alert Category

New import alert category and border testing required after reduced standards put dangerous sanitizers into hands of US consumers.

Topics

UsernamePublicRestriction

Register

LL1134044

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