Regulatory Blog

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

Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals

USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints

USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications

USFDA Guidance: GASK in Drug & Biologics: Nonclinical Info & Slide Imaging in Nonclinical Toxicology

Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator

Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement

South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1

Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)

USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations

EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages

UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"

USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products

EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR

UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF

UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device

South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS

Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects