Regulatory Blog

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Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT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FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub

EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)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