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 May Require Drug Importers To Verify Product Quality

This article was originally published in The Pink Sheet Daily

Executive Summary

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

You may also be interested in...



FDA’s PREDICT Import Screening System Working As Predicted

An initial look at data from the first year of the import screening system’s full operation finds PREDICT is effective in directing FDA inspectors to high-risk products, Deputy Associate Commissioner for Regulatory Affairs Steve Solomon says.

FDA Could Release GMP Data To Prod Manufacturing Improvements

Batch failure and other measures commonly tracked by manufacturers could be aggregated into an industry-wide index that FDA would use to help make risk-based inspection decisions.

Track-and-Trace Bill Clears House With New Electronic Labeling Language

Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.

Related Content

Topics

UsernamePublicRestriction

Register

PS075843

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