Regulatory Blog

Before approving a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), the U.S. Food and Drug Administration (FDA) must ensure that the manufacturing facilities are capable of consistently producing medicines that meet Current Good Manufacturing Practice (CGMP) requirements. Preapproval Inspections (PAIs) are conducted to evaluate manufacturing readiness, verify the accuracy of Chemistry, Manufacturing and Controls (CMC) information, and confirm that facili

The USFDA recently revised two compliance programs, which will go into effect from, October 17, 2022: Preapproval Inspections Drug...