Queries
FDA Queries Related to Drug Substances in the CMC
There are few common queries related to drug substances in the CMC (Chemistry, Manufacturing, and Controls) section. Here’s an example: 3.2. S DRUG SUBSTANCE3.2. S.1 General Information 3.2. S.1.1: Nomenclature SectionQueries: 1. USAN, BAN, IUPAC, names, CAS not provided until. 3.2. S.1.2: Structure Section Queries:Stereochemistry, Isomerism structure and discussion on ... Read More
Key Steps for Successfully Replying to Dossier Queries
Here’s a strategy chart outlining the key steps for successfully replying to dossier queries. Understand the Inquiry: Review Dossier Contents: Identify Response Components: Organize Response Structure: Gather Supporting Information: Compliance Check: Clarity and Conciseness: Transparency and Honesty: Quality Assurance: Timely Submission: Follow-Up Protocol: Documentation and Recordkeeping: Read also: Resource Person: ... Read More