FDA CDER Small Business and Industry Assistance (SBIA) Improvement Efforts

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* 1. How much experience do you have interacting with FDA?

0-3 years

3-6 years

7-10 years

10+ years

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

Hard Copy documents

Website postings

CDERLearn courses

In-person meetings

WebinarsText Messages

Other (please specify)

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

Video Conference

CDERLearn

Conference Call

Webinar

Workshop

Community Forum

Twitter

Hard Copy (regular mail)

Text Messages

Voicemail

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* 4. Have you accessed materials to educate yourself about the drug application process from a non-FDA CDER source?

Websites, if so which ones (please indicate in comment field)

Webinars, if so which ones (please indicate in comment field)

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

If you haven't accessed any materials from a non FDA CDER source, please indicate N/A

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* 5. How satisfied are you with CDER SBIA outreach?

Very Satisfied

Satisfied

Neutral

Dissatisfied

Very Dissatisfied

Very Satisfied

Satisfied

Neutral

Dissatisfied

Very Dissatisfied

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* 6. Using a scale from 1- 5, with 5 being "Highly Effective", 1 being "Not at all 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 SBIA?

	Highly Effective	Very Effective	Effective	Minimally Effective	Not at all Effective	N/A
Website	Website Highly Effective	Website Very Effective	Website Effective	Website Minimally Effective	Website Not at all Effective	Website N/A
Webinar	Webinar Highly Effective	Webinar Very Effective	Webinar Effective	Webinar Minimally Effective	Webinar Not at all Effective	Webinar N/A
Conference	Conference Highly Effective	Conference Very Effective	Conference Effective	Conference Minimally Effective	Conference Not at all Effective	Conference N/A
Tweets	Tweets Highly Effective	Tweets Very Effective	Tweets Effective	Tweets Minimally Effective	Tweets Not at all Effective	Tweets N/A
Other	Other Highly Effective	Other Very Effective	Other Effective	Other Minimally Effective	Other Not at all Effective	Other N/A

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* 7. What are the top 3 challenges you have faced during your drug application review and approval process?

1st Challenge:

2nd Challenge:

3rd Challenge:

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* 8. What are the top information products you believe CDER should provide to improve communications with small pharmaceutical businesses? (select three)

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

Sample completed application/registration forms

Searchable Q&A database

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

Guidelines for specific steps needed to comply with FDA requirements for the drug review and approval process

Information about potential sources of grants

Contact information for FDA review divisions

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

Tips for passing inspection

CDER Small Business Assistance 101: Basic information about the resources and assistance that CDER Small Business Assistance offers

Templates and mock versions of required documents. Please specify the template/required docs in comment box below.

Other (please specify in the comment box below)

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

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

Name:

Company Name:

Email Address:

Phone Number:

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* 11. What is your company/organization size?

1-9 employees

10-49 employees

50-499 employees

500+ employees