Regulatory Focus

FDA Publishes New Guidance on Aseptic Processing

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

No votes yet

ASTM Inks Agreement with Chinese Standards Body

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

No votes yet

USP Announces Harmonization of General Chapters

Parenterals and injectables are among chapters covered.

No votes yet

New Standard for Cleanrooms and Controlled Environments

The ISO report was 10 years in the making.

No votes yet

Testing Protocol Simulates Distribution Environments

Late 2004 eyed for final release of ISTA project. 

No votes yet

FDA Issues New OTC Labeling

Drugs with certain ingredients must carry warnings.

Your rating: None Average: 4 (1 vote)

FDA Mandates Bar Codes

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

No votes yet

Safe Transit

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

No votes yet

Modernizing GMPs

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

No votes yet

FDA's Five-Part Plan

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

No votes yet
Syndicate content