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FDA Regulatory Procedures Manual.
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Showing posts with label
FDA Regulatory Procedures Manual.
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From the FDA website found here.
2012 Revisions and Updates
- 08/16/2012: Chapter 9 of the Regulatory Procedures Manual (RPM) was revised and updated, as
detailed below.
- Chapter 9 - Import Operations and
Actions
- Section 9-1, subsection "Scope and Purpose," was revised to
include the following Tobacco Acts - Federal Cigarette Labeling and Advertising
Act and Comprehensive Smoking Tobacco Health and Education Act of 1986.
Section 9-6, "Recommendation Based on Multiple Samples," was
revised to include the amount "at least 25%" in paragraphs 1(b), 2(b), and 3(b),
and to also include the following language, "FDA may consider additional
information in conjunction with sample analysis when considering whether to
recommend products from a manufacturer, shipper, geographic area, or country for
detention without physical examination, such as the results of foreign
inspections and other types of information discussed in this subchapter."
Section 9-15, subsection "Background," was revised to clarify
section 801(d)(3)(B) of the Act.
- Section 9-21, Exhibits - Exhibit 9-1 was
deleted so please refer to Exhibit 9-6 instead.
Exhibit 9-2 was updated with the current version.
Exhibit 9-3 was revised to omit "tobacco products" from the
following sentence, "These laws are designed to protect you from, among other
things, unsafe or misrepresented foods, drugs, biologics, cosmetics, devices,
and other articles." The title of Exhibit 9-11 had the words
"for Special Events" added. Exhibit 9-12 was deleted as a
duplication of Exhibit 9-6. Exhibit 9-13 was
removed.