Blog Category: Biopharma

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

October 10, 2023
Biopharma

USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...

Biotech Regulatory News, Combination Products, EU Regulatory News, Marketing Authorisation, Pharma Regulatory News, Regulatory News, USA Regulatory News

Revised GMP guidelines for Pharma in India

September 26, 2023
Biopharma

The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with global standards. Larger...

Drug Manufacturing, Global Compliance, Good Manufacturing Practices, Pharmaceutical Industry, Quality Control, Regulatory Updates

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