- Sep 1
- 2 min
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway
- Aug 31
- 2 min
USFDA Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
- Aug 27
- 2 min
India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal
- Aug 27
- 2 min
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
- Aug 26
- 2 min
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
- Aug 24
- 2 min
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
- Aug 24
- 2 min
USFDA Guidance: Predetermined Change Control Plans for Medical Devices
- Aug 20
- 2 min
India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
- Aug 19
- 2 min
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
- Aug 18
- 2 min
UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)
- Aug 15
- 2 min
UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support
- Aug 11
- 2 min
USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
- Aug 3
- 2 min
Swiss Medic: Guidance on Packaging for Human Medicinal Products
- Aug 3
- 2 min
FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers