Author: admin

Consumer Health-USA and Asia Regulatory News-Sept 2023

September 26, 2023
Consumer Health

USA FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Medical Devices-Asia and ROW Regulatory News-Sep. 2023

September 25, 2023
Medical Device

ASIA INDIA (CDSCO) India puts regulations that facilitate R&D at heart of new policy on pharma and medtech India’s Department of Pharmaceuticals (DoP) has released the National Policy...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, Software Based Medical Devices

The Role of Regulatory Tracking Software in Accelerating Drug Approval Processes

September 22, 2023
Digital Health

In order to distribute the products, pharmaceutical manufacturers must ensure compliancy with global and local regulations and provide the required testing and reporting to validate products, their...

Compliance Solutions, Drug Approval, Drug Registration, Regulatory Affairs, Regulatory Management, Regulatory Tracking Software

USFDA Latest Fee Summary Table for Drugs and Devices

September 13, 2023
Medical Device

Prescription Drug User Fee Amendments FY 2023 and FY 2024 User Fee Rates Fee CategoryFee Rates for FY 2023Fee Rates for FY 2024Application Requiring clinical data$3,242,026$4,048,695 ...

Application Fee, Facility Fee, GDUFA, MDUFA, PDUFA, USFDA

Pharma/Biotech – Asia, ROW Regulatory News, Sep 2023 Vol. 2

September 12, 2023
Biopharma

ASIA Pakistan Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021 The Ethical Marketing to Healthcare Professionals Rules have been notified...

Asia Regulatory News, BioTech, ECTD Validation, Good Manufacturing Practice, Pharma, Post Marketing Surveillance, Regulatory Updates, ROW Regulatory News

Pharma/Biotech – USA, Europe Regulatory News, Sept 2023 Vol. 1

September 8, 2023
Biopharma

USA Guidance’s Released on EPCIS Standard for DSCSA Compliance, Pulmonary Disease Drug Development The FDA recommends that “trading partners” use the Electronic Product Code Information...

Biotech Regulatory News, EU Regulatory News, Good clinical practice, Pharma Regulatory News, Regulatory News, Risk management, USA Regulatory News