Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway
USFDA Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
USFDA Guidance: Predetermined Change Control Plans for Medical Devices
India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)
UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support
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