Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

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"...

Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children

Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS099461

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel