Top 7 Must Dos for a Sponsor to Achieve First Cycle FDA Approval

Author: Mukesh Kumar
1. Past Meetings With FDA Officials
Be as proactive as possible, and schedule plenty of meetings and discussions with the FDA. The more meetings and communications you have, the more successful you are going to be in most cases.
2. Issue Resolution Processes
Be responsive and pay attention to the FDA. Quickly follow up to their requests for information, and listen to their concerns. Strive to resolve issues and discuss solutions, including suggesting reasonable, acceptable alternatives.
3. Organize Meeting Venue
Prepare for each meeting as fully as possible. That includes having the right experts on hand, specific questions prepared and follow-up questions or ideas, the complete meeting information packets, etc.
4. Meeting Leader or Lead Consultant
Hire experienced personnel or consultants to lead the meetings if you are inexperienced, or are from a smaller or foreign company. Experienced companies, and US-based companies, are most successful.
5. Encourage the meeting participants to add feedback and input
Foster an open and scientific discussion environment with the FDA. Embrace open questioning and answers from both sides, and benefit from collaboration, trust and honesty.
6. Follow Up
Good communication between the FDA and the sponsors leads to faster approval and greater success. This includes meetings, follow ups and resolutions based on discussions, putting FDA recommendations into action, and more.
7. Effect of Communication Style
Remember, products which fail to gain first cycle approval often have deficiencies which could have been easily resolved with the correct communication and action or responses.

Please submit the form

what would you like to do?