As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which describes the FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending new drug application (NDA) or abbreviated new drug application (ANDA).
This guidance explains the procedures for making requests for the importation of unapproved finished dosage form drugs before final approval of the application, as well as the factors that FDA considers when granting such requests.
Furthermore, this guidance also applies to unapproved biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER) and unapproved combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA approval is anticipated.
Click on this LINK for more detailed information on Pre-Launch Activities Importation Requests.
On the same day, USFDA published 2 more guidance
o1. Voluntary Qualified Importer Program (VQIP).
VQIP (Voluntary Qualified Importer Program) allows participating importers to expedite the review process and import entry of food into the United States. Consumers and importers will both benefit from this program.
This document provides guidance on:
The benefits VQIP importers can expect to receive;
The eligibility criteria for VQIP participation;
Instructions for completing a VQIP application;
Conditions that may result in revocation of participation in VQIP; and
Criteria for VQIP reinstatement following revocation.
This guidance document is presented in question-and-answer format.
Click this LINK for more detailed information on Voluntary Qualified Importer Program (VQIP).
2. Initiation of Voluntary Recalls Guidance
Earlier this week, the US Food and Drug Administration (FDA) released detailed guidance for regulated industries to help them recall violative products quickly.
The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices.
Click this LINK for more detailed information on Initiation of Voluntary Recalls Guidance
Commentaires