USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
Guidance documents for Therapeutic Products
Swissmedic - Guidance on known Active Pharmaceutical Substance & Time limits for Authorisation
EMA- New Guidance on Complex Clinical Trials
HPRA Guide to Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
TGA guidance on Testimonials & Endorsements in Advertising
Free eBook- CAPA in the Pharmaceutical and Biotech Industries
SAPHRA - Guideline on Availability of Medicines for Use in a Public Health Emergency (PHE)
USFDA- Q&A Guide on Importation of Prescription Drugs from Canada
EMA - Guideline on Treatment of Bacterial Infections
USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
Guidance on Clinical Trial Applications -
Generic Drug User Fee Guidance - Assessing User Fees - USFDA
USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
EMA's IRIS Guide for Applicants - On How to Create & Submit Scientific Applications
SwissMedic - Technical Requirements for the Submission of Clinical Trial Application
SFDA - Guidelines for Variation Requirements
USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product