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"...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.