Request for Surveys and Focus Groups in Support of FDA Programs for Small Pharmaceutical Businesses

Proposed Survey Questions

1. How much experience do you have working with FDA?

• 0-3 years

• 3-6 years

• 7-10 years

• 10+ years

2. How do you currently receive information from CDER SBAP? (select all that apply)

   • Email

   • Hard Copy documents

   • Website postings

   • CDERLearn courses

   • In-person meetings

   • Webinars

   • Text Messages

   • Other ____________________

3. What are your most preferred means for receiving FDA related information? (select three)

• Email

• Video Conference

• CDERLearn

• Conference Call

• Webinar, Workshop

• Community Forum

• Twitter

• Hard Copy (regular mail)

• Text Messages

• Voicemail

4. Other than the CDER outreach materials, have you accessed materials to educate you about the drug application process?

• Websites, if so which ones __________________

• Webinars, if so which ones __________________

• Training or other educational materials from another organization. If so, which organization(s)? __________________

• I have not accessed any materials from a non FDA CDER source

5. How satisfied are you with CDER SBAP’s outreach? (1-Very Satisfied: 5 – Very dissatisfied)

6. Using a scale from 1- 5, with 5 being most effective, 1 being least effective, and N/A to indicate you haven’t accessed the item, how would you rate the effectiveness of the current materials and information developed by CDER SBAP?

• Website

• Webinar

• Conference

• Tweets

• Other

7. What are the top 3 issues you have had getting your drug application reviewed and approved?

   • _________________

   • _________________

   • _________________

8. What are the top 3 information products you believe CDER should provide to improve communications with small pharmaceutical businesses? (Select from list below)

• FDA 101 Material: Introduction to the basic operations, authorities, processes and requirements of the FDA

• A directory of official and unofficial industry guidance sources

• Checklists for different stages and processes

• A forum where small pharmaceutical businesses in need of specialized services and consultants offering such services can connect

• Sample completed application/registration forms

• A forum where small pharmaceutical businesses can share advice and best practices

• NDC numbers for raw materials

• Information about potential sources of grants, loans, or alternative financing

• Step-by-step process guide for bringing a new drug to market

• CDER SBAP 101: Basic information about the resources and assistance that CDER SBAP does and does not offer, as well as CDER administrative personnel and processes

• Lists of currently applicable regulations for a product/process type, and identification of potential regulations that may be applied in the near term

• Searchable Q&A database

• List of specific steps needed to comply with FDA requirements for specific products/processes

• Enhanced options for emailing CDER SBAP and obtaining a specific response to a question

• Information about average or approximated cost ranges for specific steps/processes

• Average timelines for specific steps/processes

• Comparison of US and EU requirements

• Contact information for subject matter experts inside FDA

• Tips for Passing Inspection

• Templates and mock versions of required documents

• Other ______________________________

9. Please provide any other comments to help CDER SBAP improve their communication methods.

_________________________________________________

10. Would you be open to providing follow-up information? If yes, please provide your name, email and phone number below.

    • Name __________________________________

    • Name of Company ________________________

    • Email Address ___________________________

    • Phone Number ___________________________

11. What is your company/organization size?

    • 1-9 employees

    • 10-49 employees

    • 50-499 employees

500+ employees