MDCG Med Dev: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams
MDCG Med. Dev Guidance: Qualification of In Vitro Diagnostic Medical Devices (IVDs)
Australia TGA: eCTD AU Module 1 and Regional Information v3.2
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
USFDA Med Dev Guidance: Biocompatibility Testing and Accreditation Scheme for Conformity Assessment (ASCA) Program
USFDA Guidance: Appeal Options for Mammography Facilities
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
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
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
USFDA Guidance: Predetermined Change Control Plans for Medical Devices
UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
USFDA Guidance: Application User Fees for Combination Products
New EU Regulations on AI in Medical Devices: Key Insights and Implications
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software