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
Guide to Clinical Trials conducted under the CTR in Ireland
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
USFDA Guidance on Electronic PostMarketing Safety Reporting
Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA
SFDA's Product Classification Guidance
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
FDA's Bioavailability Guidance for NDAs or INDs- General consideration