USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
Swiss Medic: Guidance on Packaging for Human Medicinal Products
FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
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
Swissmedic Guidance: Product Information for Human Medicinal Products
EU Guidance: Procedural Advice on Paediatric Applications
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
Swissmedic Guidance: Formal Requirements and SwissPAR
ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines