FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval
The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).