- Jul 31
- 3 min
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
- Jul 29
- 2 min
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
- Jul 27
- 2 min
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
- Jul 27
- 2 min
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
- Jul 27
- 2 min
USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
- Jul 23
- 2 min
Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway
- Jul 23
- 2 min
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
- Jul 22
- 2 min
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
- Jul 20
- 1 min
SAPHRA Guidance: Guideline On Co-Applicancy
- Jul 20
- 2 min
USFDA Guidance: Pediatric IBD Drug Development, Clin.Pharmacology Considerations and BP-Pulse Donor Eligibility Requirements
- Jul 20
- 2 min
EMA Guidance: EudraVigilance Registration Manual
- Jul 16
- 2 min
USFDA Guidance: Application User Fees for Combination Products
- Jul 15
- 2 min
New EU Regulations on AI in Medical Devices: Key Insights and Implications
- Jul 13
- 2 min
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
- Jul 13
- 2 min
Swissmedic Guidance: Product Information for Human Medicinal Products
- Jul 13
- 2 min
USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD
- Jul 11
- 2 min
EU Guidance: Procedural Advice on Paediatric Applications
- Jul 10
- 2 min
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
- Jul 9
- 2 min
USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
- Jul 8
- 2 min
USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products