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 Considering Manufacturer Contracting Guidance

Executive Summary

Document could provide more detail on the agency’s contractor management expectations, which now are covered in several different documents.

You may also be interested in...



FDA May Require Drug Importers To Verify Product Quality

Public meeting will solicit stakeholder comments on how FDASIA-mandated import regulations should be implemented as the expedited entry program reemerges.

Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation

FDA will need a bit of time to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished dosage forms for the U.S. market as part of the proposed generic drug user fee program.

Drug Shortages: Can The Blame Game Help Find Solutions?

The effort to prepare for and prevent drug shortages resembles a “he said, she said” argument between FDA, practitioners and industry, where the actual cause of many shortages remains a matter of debate.

Related Content

Topics

UsernamePublicRestriction

Register

PS054062

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