Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
Health Canada: Guidance on Master Files Procedures & Administrative Requirements
Singapore's HSA: Regulatory Updates for Therapeutic Product Registration
Philippines FDA: Publishing of Package Insert & PIL of Registered Drug Product in Verification Port
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
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
Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
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
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
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