Suitability Petitions for ANDAs
Suitability Petitions for ANDAs An ANDA suitability petition is …
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US Vs EU - Q1 & Q2 Sameness Requirements for Regulatory Filings
Q1 & Q2 Sameness Requirements for Parenteral Generic Product Filings - US Vs EU …
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What is European Public Assessment Report (EPARs) and Periodic safety update reports (PSURs)?
What is European Public Assessment Report (EPARs) and Periodic safety update reports …
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Markeeting Authorizations (MA) Validity and Renewal in European Union
Marketing Authorizations (MA) Validity and Renewal in EU – Interesting Facts …
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USFDA’s User Fee Programs - PDUFA/MDUFA/GDUFA/BsUFA/ADUFA/AGDUFA
The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of pro…
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What is the difference between GDUFA and PDUFA?
Both GDUFA and PDUFA are US FDA’s User Fee programs, which help FDA to hire and retain sufficie…
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What is the difference between Reference Listed Drug (RLD) and Reference Standard (RS) in Orange Book?
Reference Listed Drug (RLD): An RLD is the specific listed drug on which an ANDA applicant reli…
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What is the difference between Biologic and Bio similar ?
Biologic or biological products are medicines made from living organisms through highly complex…
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FDA Letters to the industry (Warning Letter and Untitled Letter)
FDA Letters to the industry (Warning Letter and Untitled Letter) If a person or fi…
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Dossier Comparison US vs Europe / Difference between US and Europe Regulatory Filings
The path a drug travels from a lab to patient is usually long, and every drug takes a unique…
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RTR - Refuse to Receive standards for ANDA and PAS Filings - USFDA
When an applicant submits an ANDA to agency, OGD (Office Generic Drug…