Pink Sheet 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

OGD Hopes To Reach 315 ANDA Approvals In 2000, Up 30% Over Slow 1999

Executive Summary

FDA's Office of Generic Drugs estimates it could approve or tentatively approve 315 generic drug applications in calendar year 2000, a 30% increase from 1999.

You may also be interested in...



FDA Expects To Review Half Of All Generic Drugs By Six-Month Goal In 2001

FDA projects it will be able to review 50% of generic drug applications within six months in FY 2001.

FDA Expects To Review Half Of All Generic Drugs By Six-Month Goal In 2001

FDA projects it will be able to review 50% of generic drug applications within six months in FY 2001.

Telephone/Fax Amendments Are "Highest Priority" For ANDA Reviewers

Telephone and facsimile ANDA amendments will be designated as "highest priority" by FDA reviewers, the agency says in its recent guidance on "Major, Minor, Fax and Telephone Amendments to Original Abbreviated New Drug Applications."

Latest Headlines
See All
UsernamePublicRestriction

Register

PS036104

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