Regulatory Focus

FDA Publishes New Guidance on Aseptic Processing

The document contains new sections on blow-fill-seal technology. 

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ASTM Inks Agreement with Chinese Standards Body

Signing is the latest step in the organization’s involvement in China.  

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USP Announces Harmonization of General Chapters

Parenterals and injectables are among chapters covered.

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Testing Protocol Simulates Distribution Environments

Late 2004 eyed for final release of ISTA project. 

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New Standard for Cleanrooms and Controlled Environments

The ISO report was 10 years in the making.

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FDA Issues New OTC Labeling

Drugs with certain ingredients must carry warnings.

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FDA Mandates Bar Codes

FDA-registered firms with existing products have two years to comply

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Safe Transit

USP offers information on storage and shipping, but no requirements.

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Modernizing GMPs

A one-year report card shows new technologies are being considered to make drug packaging and other activities safer and more efficient.

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FDA's Five-Part Plan

The agency launches a strategic action plan to address new challenges to the public health.

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