FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

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).

Anvisa approves new HIV treatment

Brazil’s National Health Surveillance Agency (Anvisa) has approved a new drug for the treatment of HIV that combines two different substances in a single tablet.

FDA publishes ICH Q12 guideline for Post Approval CMC changes

Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product.  Regulatory tools and […]