FDA
Clinical, Procedural
01/03/23
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
EMA
Clinical
07/02/23
Clinical Trials Information System - Risk mitigation plan
Clinical, General
13/01/23
ICH guideline M10 on bioanalytical method validation and study sample analysis – Frequently Asked Questions (FAQ)
General, Post-approval
28/11/22
ICH guideline Q3C (R8) on impurities: guideline for residual solvents - Step 5
Clinical, General, Post-approval
18/11/22
Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle
ICH
26/10/22
ICH M11 guideline, clinical study protocol template and technical specifications - Step 2b
10/10/22
ICH: Q 5 A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 2b
03/10/22
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Clinical, Post-approval
Q13 Continuous Manufacturing of Drug Substances and Drug Products
Procedural
06/02/23
ICH Q9 Quality risk management - Scientific guideline
Post-approval
12/12/22
Post-Notice of Compliance (NOC) Changes – Quality Guidance
Procedural, Post-approval
22/11/22
Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 3
Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy
21/10/22
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
05/10/22
Competitive Generic Therapies
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
15/02/23
Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation
23/01/23
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
02/12/22
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
21/11/22
Access Consortium statement on Good Manufacturing Practice inspections reliance and recognition evidence
10/11/22
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
13/10/22
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
28/09/22
ICH Q2-14 QUALITY GUIDELINE ANALYTICAL PROCEDURE DEVELOPMENT
