FDA Changes Its Food Webpages

Updated June 26, 2024

The original links broke.

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New Era of Smarter Food Safety - FDA.gov

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News & Events > Learn About the Changes to FDA.gov/Food:

"Welcome to FDA.gov/Food. If you have used this website before, you may have noticed that we’ve made some changes since your last visit. This page explains why we made changes to the Food section of FDA.gov. It also highlights the major changes so that you can quickly navigate to some of our most popular content.

• Why did you make changes to the Food section?
• What happened to some of the pages I used to frequent?
• What improvements have you made?
• What content has moved and where is it now?
• Have a question or suggestion?

'via Blog this'


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FDA CFR Title 21 Database Search Page - Excellent!

Initially, I wasn't too thrilled about the FDA website getting re-designed. Now I'm starting to like what I'm seeing. For example, I'm seeing more user friendly pages like the CFR Search page. If you don't have the Search CFR Title 21 Database page bookmarked, you really should. It's a terrific database search tool for finding CFR contents by:

• Section number
• Part number
• Full text search

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FDA - Proposed Regulatory Changes For SUDs

The FDA has submitted the following proposed collection of information to OMB for review and clearance: Guidance for Industry and Food and Drug Administration Staff; Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-Use Device Labeling'') (Federal Food, Drug and Cosmetic Act, Section 502(u)) (OMB Control Number 0910-0577) -- Extension. This is about requiring devices (both new and reprocessed) to bear prominently and conspicuously, the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. 

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FDA Draft Guidance - Drug Supply Chain and SNIs

• Respected FDA GMP online training programs and courses offered by SkillsPlus International Inc.

Updated October 24, 2022:

I'm glad to see these new proposed standards. With the presence of drug counterfeiting, diversion, and quality issues, I'm hopeful these standards can bring greater safety and confidence to the supply chain. This FDA Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. The details of the draft guidance follow . . . TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND A. Food and Drug Administration Amendments Act of 2007 B. Scope of this Guidance III. STANDARDIZED NUMERICAL IDENTIFIERS A. What should be designated as a package-level SNI? B. Does the SNI include expiration date and/or lot or batch number? C. Why did FDA select the serialized NDC for package-level SNI? Do you agree with the direction this FDA draft guidance is taking us? 

Related Posts: FDA Draft Guidance On Good Importer Practices FDA - Global Drug Supply Chain Needs Better Oversight CA E-Pedigree - Pedigree and Serialization 

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About The FDA Orange Book - Slide Deck (free)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .

• What is the Orange Book?
• What is exclusivity and how does it work?
• How is the Food and Drug Administration (FDA) involved with patent protection?

Related Posts:
FDA Orange Book - Online

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