Regulatory Focus

FDA Proposes to Delete Warning Label on Hormone

FDA finds that there is no reliable evidence showing that drugs with progesterone cause birth defects.

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Sealed Two-Piece Capsules Mandatory

Only one tamper-evident packaging feature now required.

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GPO Picks GS1

Global Trade Item Numbers will be required on packages.

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Tall Man Lettering

Safety experts discuss a method to prevent medication errors.

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Graphical Medical Language

A new system of symbols to communicate patient conditions relies on visuals.

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FDA Updates List of Consensus Standards

Check this list to be sure you are consulting the most up-to-date medical packaging standard�or find one you haven�t used before.

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Increasing Importance of DMFs for U.S. Exporters to Mexico

Proper submission and regular maintenance of Drug Master Files are gaining a new level of importance for any company that wants to successfully supply the Mexican pharma market.


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A Drug by Any Other Name

Experts think FDA's new drug name approval processs is a work in progress. Could packaging help?


An attempt to streamline FDA’s name approval process for new drugs has prompted responses. In June, FDA accepted feedback from industry leaders for its Pilot Program to Evaluate Proposed Name Submissions to consider new terms for approval.