The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format
FDA wants to inform you of the Federal Register (FR) notice announcing a public workshop on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format,” that published 4/2/2014.
This public workshop is intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs, in addition to the feasibility of establishing standardized documentation to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot-level data.
FDA will hold the public workshop May 8-9, 2014, at FDA’s White Oak campus in Silver Spring, MD.
You must register by April 24, 2014. Registration is free. Seats are limited. For more information and registration instructions, please visit our website for this public workshop.
To submit comments to this docket, please follow the instructions in FR notice.
Please share this information with other groups or individuals that may be interested.
For more information on the Drug Supply Chain Security Act, please visit these web pages:
FDA’s DSCSA webpage: http://www.fda.gov/Drugs/
DSCSA implementation plan webinar: http://www.fda.gov/Drugs/
Send questions to: DrugTrackandTrace@fda.hhs.gov
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
Please take our CDER Small Business survey: https://www.surveymonkey.com/
.png)
No hay comentarios:
Publicar un comentario