505(b)(2) vs ANDA: Which Filing Should You Choose? Complete Comparison 2026 By PharmaShare Regulatory Team | US FDA Pathways | August 2026 Quick Answer: ANDA is for exact copy of brand (same dose, same form). 505(b)(2) is for modified version – new strength, new form, new route, new indication. ANDA is cheap & fast ($2-5M). … Read more
What is 180-Day Exclusivity in US? The $100 Million Prize for First Generic By PharmaShare Regulatory Team | US FDA Generic Strategy | August 2026 Quick Answer: 180-Day Exclusivity is a 6-month monopoly given by USFDA to the First Company that files an ANDA with Para IV challenge and wins. For those 180 days, FDA … Read more
What is Orange Book & How to Read It? Complete Guide for Generic Pharma By PharmaShare Regulatory Team | US FDA Regulatory | August 2026 Quick Answer: Orange Book is the FDA’s official list of all approved drugs + their patents + exclusivity + generic equivalents. If you work in Regulatory, R&D, IP or Business … Read more
Types of ANDA Filing in the US: Para I, II, III, IV Explained with Examples By PharmaShare Regulatory Team | US FDA Regulatory Affairs | August 2026 Quick Answer: An ANDA can be filed under 4 Paragraph Certifications (I, II, III, IV). Your Para filing decides if you launch immediately, wait for patent expiry, or … Read more
What is RFAR in Europe? RFAR stands for Rapid Field Alert Report. In EU terminology it’s directly linked to FSCA – Field Safety Corrective Action for medicinal products. Definition: An urgent communication to Competent Authorities and customers regarding actions taken to reduce risk of a defective medicinal product already on the market. Key EU Regulations … Read more
FDA and Global Regulatory Inspection Expectations for CPV Regulatory authorities expect Continued Process Verification (CPV) to be an integral part of the Pharmaceutical Quality System (PQS). During inspections, investigators typically evaluate whether manufacturers have established a scientifically justified and risk-based program to continuously monitor commercial manufacturing processes. Inspectors commonly review: Documented CPV procedures and responsibilities … Read more
Marketing Authorization Approval Process in Europe | Complete Guide to EU Pharmaceutical Registration Marketing Authorization Approval Process in Europe: Complete Regulatory Guide Obtaining a Marketing Authorization (MA) is one of the most important milestones in bringing a pharmaceutical product to the European market. Before any medicinal product can be marketed within the European Union (EU) … Read more
Variation Filing in Europe: A Complete Guide for Pharmaceutical Regulatory Professionals Variation Filing in Europe – Complete Regulatory Guide Once a medicinal product receives marketing authorization in the European Union (EU), its lifecycle does not end. Pharmaceutical companies frequently implement changes to manufacturing processes, analytical methods, packaging materials, manufacturing sites, quality controls, safety information, and … Read more
FMEA Application in Pharma | ICH Q9 R1 Risk Management Guide + Template 2026 Application of FMEA Tool in Pharma Risk Management: Complete ICH Q9 R1 Guide 2026 Published: April 19, 2026 | Category: Quality Risk Management | Reading Time: 8 min Failure Mode and Effects Analysis = FMEA. It’s the first QRM tool USFDA … Read more
ANDA Approval Process in USFDA: Complete Guide for Generic Drug Approval 2026 Want to launch a generic drug in USA? You need ANDA – Abbreviated New Drug Application approval from USFDA. Unlike NDA for innovators, ANDA proves your generic is same as Reference Listed Drug RLD in safety + efficacy. This guide covers ANDA vs … Read more
