Regulatory Focus

Protecting High-Risk Products

FDA's latest report on anticounterfeiting stresses the importance of working toward an electronic track-and-trace tactic to fighting fakes.

 

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Bar Code Rules Clarified—Again

FDA expects immediate compliance, but it will allow existing drug supplies without bar codes to be distributed.

By Daphne Allen

Now that it is official, FDA’s bar code rule is getting some further clarification. In April, the agency released a new guidance, “Bar Code Label Requirements, Questions and Answers.” According to the rule, certain drug and biological products commonly used in hospitals must carry a linear bar code containing the National Drug Code (NDC).

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Working Toward a Consensus on RFID

FDA brings dozens of experts together to discuss RFID's role in anticounterfeiting.

By Daphne Allen

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Delivering One Globally Harmonized Document

Two standards are combined and edited for clarity and ease of use.

By Stephanie Steward

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FDA Unveils New Package Insert Format

Final rule calls for 6- and 8-point type.

David Vaczek
Senior Editor

 

Five years after first proposing a new format for the prescription drug package insert (PI), FDA on January 18 issued a final rule (docket number 2000N-1269). The rule represents a “major revision” of the drug labeling and the first overhaul of the PI in more than 25 years.

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Preparing and Packaging for Flu Pandemic

by Daphne Allen, Editor

FDA asks manufacturers to protect products with packaging that deters counterfeiting and tampering.

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Firms Prepare for XML Standards

FDA’s Structured Product Labeling initiative is changing label-content management.

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Regulatory Focus: Pinning Down New Labeling Rules

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Regulatory Focus:

FDA releases guidance for those grappling with labeling revisions.

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FDA Guidance Addresses Vaccine Labeling

New document reviews agency’s requirements. 

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