USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
SFDA Guidance: Conditional Approval for Medicinal Products for Human Use
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
USFDA's Notice: CMC Development & Readiness Pilot Program
DRAP Guidelines: Preparation of Summary of Product Characteristics (SmPC)
SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels
Denmark DMA: Current Danish QRD Template for Granting MA
USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections