Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
USFDA Guidance: GASK in Drug & Biologics: Nonclinical Info & Slide Imaging in Nonclinical Toxicology
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects
Swiss Medic: Guidance on Transfer of Marketing Authorisation
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
Health Canada: Guidance on Nitrosamine Impurities in Medications