Guidelines

CDSCO Guideline for Action on Spurious &

Amidst the heightened surveillance and enforcement actions initiated by different state licensing authorities (state FDAs)

FDA issues Guidance on Container Closure

The USFDA has released a new draft guidance, Container Closure Systems for Human Drugs and

USFDA Issues Guidance for Impurity Speci

The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April

Responding to FDA Form 483: USFDA Issues

The USFDA has released a draft guidance titled “Responding to FDA Form 483 Observations at