The Business Implications Of The New FDA Drug Listing Requirements

There’s also Distributors Listings, which are listings done where the marketing category is OTC Monograph Final/Not Final, any one of the “unapproved” marketing categories such as unapproved medical gas, any of application type marketing categories such as NDA, or any of the other marketing categori...

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Bibliographic Details
Published inPharmaceutical Processing
Main Author Shatz, Howard
Format Trade Publication Article
LanguageEnglish
Published Rockaway Advantage Business Media 18.12.2017
Subjects
Codes
Descriptive labeling
House brands
Laboratories
Manufacturers
Manufacturing
Marketing
United States > US
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Summary:There’s also Distributors Listings, which are listings done where the marketing category is OTC Monograph Final/Not Final, any one of the “unapproved” marketing categories such as unapproved medical gas, any of application type marketing categories such as NDA, or any of the other marketing categories other than a bulk ingredient, drug for further processing, or manufacturer under contract. Detailing How to Meet the Latest FDA Drug Listing Regulations To catch up, we recommend contacting the FDA’s Electronic Drug Registration and Listing System (EDRLS; edrls@fda.hhs.gov) group for the setId and version numbers for the listing(s) for a particular NDC, product code, or labeler code, to verify what was the last listing. [...]moving forward with a disciplined approach it will be much simpler and ensure that the FDA has the latest information to ensure the safety of our nation’s drug supply. ______________________________________________________ About the Author Howard Shatz is SPL Project Manager at Data Conversion Laboratory (DCL, www.dclab.com).
ISSN:1049-9156