• Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products
  • Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for …
  • Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)
  • Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications
  • Notice: Submission Filing Recommendations for Veterinary Drugs - Good Manufacturing Practices and …