USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
MHRA Guidance: Licensing of Biosimilar Products
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
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 Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
USFDA's Notice: CMC Development & Readiness Pilot Program
USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
USFDA Guidance: Multiple Guidances related to Oncology
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
MHRA Guidance: Good Clinical Practice for Clinical Trials
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
Artificial Intelligence in Regulatory Affairs
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
Swissmedic Guidance: eDok Submission Update
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics