Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process
Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
EMA Guidance: Paediatric Submissions Via Syncplicity Web Client
MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
Philippines FDA: Guidelines on the Application for License to Operate
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials
DRUGWATCH: Off-Label Drug Use: What You Need to Know