USFDA Statement: New Patient Medication Information - Medication Guide for Patients
EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
India CDSCO Guidance: 3 IVD Draft Guidances for Consultation
Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT
USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages
USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
Cybersecurity of Legacy Medical Devices - Guidance-IMDRF
USFDA: Activities and Engagement with the Voluntary Improvement Program
Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA
Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Malaysia’s MDA- Draft Medical Device Labeling Guidance
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA
FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)
ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
ICH's updated Draft Guidelines on Analytical Method Development