Sunday, November 25, 2018
Simplified Roadmap for ANDA/NDA Submission and Approval will change Pharma Landscape
1. Lower approval time will lower regulatory costs and improve affordability.
2. With faster approval companies will be able to have additional revenues.
3. Drugs would be available to the patients sooner than the current times.
Company can take whatever time they needed for the initial submission. Once the company submits its application and FDA receives the submitted application that day becomes DAY ONE.
2. Can the Review and Approval Process for ANDA at USFDA be Reduced from Ten Months to Three Months?
3. ANDA (Abbreviated New Drug Application) / NDA (New Drug Applications) Filing Simplification: Road Maps are a Must.
4. What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days?
5. APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE,
6. 21CFR Part 314 Applications for FDA Approval to Market a New Drug,
9. Ya, Dr. Naiqi, Deputy Director, Division of Chemistry IV Office of Generic Drugs, , Accessed November 14, 2018
10. Sullivan, Thomas: FDA ANDA Submissions Content and Format of Abbreviated New Drug Applications, , May 6, 2018 accessed November 10, 2018