FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers
Most responses to the FDA request for comments on their draft Q&A guidance on DSCSA product identifiers align with those of the HDA.
Most responses to the FDA request for comments on their draft Q&A guidance on DSCSA product identifiers align with those of the HDA.
Verification Systems under the DSCSA are the things that FDA (and probably state) inspectors are going to look for whenever they visit your facilities from now on. Are you ready? This new draft guidance will help you.
An SNI is not equivalent to an SGTIN. And that’s where the problem starts.
483s issued to other companies in the supply chain are valuable resources for companies to analyze so they can learn how the FDA interprets certain sections of the Food, Drug and Cosmetics Act (FD&C) before their own facilities are inspected.
Two final DSCSA guidance documents and one new draft DSCSA Q&A document now available for download.
IQPC interviews pharma supply chain industry veteran, Kevan MacKenzie of McKesson.
Does the DSCSA have a “spirit”? Yes, but it’s not what you think it is. And the FDA just admitted the problem of illegitimate drugs is a lot smaller than it thought a few years ago.
M&A of drug manufacturers are going to be more complex and more risky than they have in the past. That means they will be more costly too.
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