Pink Sheet is part of the Informa Intelligence Division 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

Getting Organized for GDUFA: FDA Elevates Generic Review Activities Under New Director Geba

This article was originally published in RPM Report

Executive Summary

In the two months since the enactment of the Generic Drug User Fee Act, FDA has announced a major recruitment from the brand sector to head its generic drug activities (Gregory Geba), approved one controversial transdermal generic (Watson’s lidocaine topical patch), and elevated the generic review activities to “Super Office” status.

Advertisement

Related Content

FDA’s Woodcock to Head Office of Pharmaceutical Quality; New Details Emerge
Growing Pains for Generic Drugs: OGD Gains Respect, But Loses Geba
GDUFA Implementation Will Be Overseen By Mylan’s Representative in the House
UFA Creep: Time to Apply the Brake?
The Limitations of Antibiotic Incentives
FDA’s Latest PR Push: Protecting the Reputation of Generic Drugs
Biosimilars: Inverting the Innovator Development Model

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS081038

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