USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
SAPHRA Guidance: Guideline On Co-Applicancy
USFDA Guidance: Pediatric IBD Drug Development, Clin.Pharmacology Considerations and BP-Pulse Donor Eligibility Requirements
EMA Guidance: EudraVigilance Registration Manual
USFDA Guidance: Application User Fees for Combination Products
New EU Regulations on AI in Medical Devices: Key Insights and Implications
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
Swissmedic Guidance: Product Information for Human Medicinal Products
USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD
EU Guidance: Procedural Advice on Paediatric Applications
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products