Update Nov Dec 2013 - (Page 41)

FDLI Activities one division will deal with premarket and product labeling compliance and the other with manufacturing quality. Wolf elaborated and said the shift will allow the staff to focus on discrete issues, rather than a broad compliance policy. Many of the remaining questions focused on compliance and the repercussions when FDA alleges noncompliance. Multiple attendees asked about what happens if a company identifies a violation in their materials - What should they do? Should they call FDA? Should they just discontinue the marketing piece? There was a common theme in all of the answers: pull the materials, call the appropriate FDA officials to inform them of the problem, and follow up with a letter identifying the problem and the company's actions. The panelists also suggested that the company investigate how and why the problematic piece was released and send FDA a follow-up letter after the conclusion of the investigation. Another attendee asked about CDER's practice when a company has a violation for one product, particularly whether CDER focuses its monitoring efforts on that one product or watches the entire company more carefully. Thomas Abrams replied that whenever CDER sends a company an untitled letter, CDER expects that the entire company will institute any necessary changes and not just change the materials related to one product. Abrams also noted that if CDER notices there are problems across a company's products, they will ask company representatives for a face-to-face meeting. Toward the end of the session, the panelists concentrated on questions pertaining to electronic submissions. Abrams said that CDER is close to accepting electronic submissions and interested parties should look out for forthcoming guidance on the matter. He is hopeful that CDER will start to accept online submissions in 2014. Lisa Stockbridge mentioned that CBER has been accepting electronic submissions for several years, but has encountered a few wrinkles when companies start the process electronically then follow-up with paper submissions. She suggested that whichever way companies submit the materials, they pick a medium and stick with it. FDLI Instant Access, Purchase and Download Now fdli Primers Be on the lookout for these soon-to-be-published Primers importing food into the United states importing dietary supplements into the United states importing Cosmetics & Consumer Health Products into the United states FDLI Primers offer practical, how-to guidance on contemporary food and drug law topics. A full list of published Primers is available online: fdli.org/primers Primer.indd 1 FDLI November/December 2013 Update 11/12/13 11:19 AM 41 http://www.fdli.org/primers

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013