Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Updated recordkeeping guidance

This article was originally published in The Tan Sheet

Executive Summary

Clarification of FDA's differentiation between the noun "packaging," the verb "packaging" and "packing" is one issue the agency addresses in the third edition of "Questions & Answers Regarding Establishment & Maintenance of Records." The Center for Food Safety & Applied Nutrition published the document on its website June 7. The guidance answers "various questions" about FDA's final rule on recordkeeping, which the agency published in December 2004 as a result of the Bioterrorism Act of 2002. The document was last updated in November (1"The Tan Sheet" Nov. 28, 2005, In Brief). Comments on the guidance may be submitted "at any time," the agency notes...

You may also be interested in...

Revised recordkeeping guidance

"Two subsidiaries share the same facility. Does this regulation require the establishment and maintenance of records when food is transferred from the possession of one subsidiary to the other?" is one of the questions FDA answers in the second edition of "Guidance for Industry: Questions & Answers Regarding the Final Rule on Establishment and Maintenance of Records" published in the Federal Register Nov. 22. The agency will "periodically" update the guidance due to the "large number" of questions it has received regarding the final rule on recordkeeping published by the agency in December 2004 as a result of the Bioterrorism Act. The first edition of the guidance was published in September 2005 (1"The Tan Sheet" Sept. 12, 2005, In Brief). Comments on the rule may be submitted "at any time"...

Interview: OurCrowd CEO Jon Medved On Israel’s Medtech “Boomtown”

With $1.3bn invested in over 200 high-tech start-ups, OurCrowd is now sharpening its focus on medtech. Medtech Insight spoke to founder Jon Medved to find out more.

Keeping Track: Quick Trips From Breakthrough Designation To Market

Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts