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                FDA Basics for Industry

FDA Basics for Industry

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          FDA Basics for Industry
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDAFDA Basics for Industry For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
  
  	
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    PrintTrade associations and industry-based groups should use this questionnaire to submit **cross-agency**speaker requests (i.e. two or more FDA-regulated product areas) for a single event. Please note that this is NOT an event planning or travel related service.

For events held within the contiguous United States, please provide **3 to 4 months'** notice. For events held abroad, and in Alaska and Hawaii, please provide **4 to 6 months'** advance notice. Emerging regulatory demands and other commitments may limit our level of participation when we receive less notice. For more information about the process, please see Requesting Cross-agency Speakers from FDA.

To complete this questionnaire, please follow these steps:

Gather documents or website addresses for the event agenda, the invitation written on your organization's letterhead and other pertinent information you may want to submit
	Enter all the speaker requests for each event during a **single** session. Once submitted, the questionnaire won't be available to add new speakers or information. **DO NOT** press the back button in your browser; you will lose your data, and your form will be incomplete.
	Set aside 15 minutes to fill out the questionnaire initially, but subsequent requests for speakers at the same event will pre-populate the fields making it quicker to submit the entire request.**Internet Explorer (IE) is the only officially supported browser for FDA websites. Other browsers (Chrome, Firefox, Safari, etc.) have not been verified and may prevent successful form submissions.**

For more information see Frequently Asked Questions below or email us at FDASpeaks@fda.hhs.gov.

Request Speaker Here

Frequently Asked Questions

What if my request pertains to only one FDA-regulated product (e.g., drugs, food, biologics, medical devices, tobacco, dietary supplements, cosmetics, and animal drugs and feed)?
	Please select the best topic below, and then use the contact information to inquire directly with that FDA-regulated product area. Someone from that product area will provide further guidance regarding speaker request that involves only one FDA-regulated product area.

Topic
			Contact InformationAnimal & Veterinary
			AskCVM@fda.hhs.govBiologics, Blood, and Vaccines
			CBERSpeakerLiaison@fda.hhs.govCosmetics
			CFSANExecSec@fda.hhs.govDietary Supplements
			CFSANExecSec@fda.hhs.govDrugs
			CDERSpeakerRequests@fda.hhs.govFoods
			CFSANExecSec@fda.hhs.govMedical Devices
			CDRHSpeakerLiaison@fda.hhs.govRadiation-Emitting Products
			CDRHSpeakerLiaison@fda.hhs.govTobacco Products
			AskCTP@fda.hhs.govInspections and Enforcements
			ORAAppearances@fda.hhs.govFor any other FDA regulated product not listed above including the Office of the Commissioner activities, Email: FDASpeaks@fda.hhs.gov

How do I request two or more FDA speakers to address a broad range of topics?
	To request **two or more** FDA speakers from our various units, complete the FDA Speaker Questionnaire.

How long does it take FDA to accept a speaker request?
	Please give us as much notice as possible when requesting a speaker. For events in the contiguous United States, 3 to 4 months' advance notice is ideal. For events abroad, and in Alaska and Hawaii, we need 4 to 6 months' advance notice.

We accept requests with shorter notice, but are less likely to be able to provide you with a suitable speaker.

Can a specific speaker be requested?
	Yes. Please tell us if you would like a particular person or someone with a specific expertise. Please be flexible. Your first choice might not be available, so we recommend that you include a second and third choice in your request.

What happens after my request has been submitted?
	The Office of External Affairs (OEA) will contact the appropriate office(s) within FDA to obtain official clearance. If more information is needed, we will work with your organization to gather it.

Some factors that might be used in considering requests include: timeliness of the topic, geographic location of the event, the event's target audience, FDA staff availability, expected number of attendees and available resources.

Once your request has been processed, OEA will contact you.

Overview of the clearance process:

1. You submit an online speaker request via the FDA Speaker Questionnaire and receive an automated email confirmation.
2. FDA might email or telephone you with questions or to clarify your request.
3. FDA will contact you once we have processed your request. Our primary mission is to protect and promote the public health. Speaker requests received from trade groups are prioritized according to our core regulatory responsibilities and the available resources. We remain committed to meeting the continuing challenges or regulating in an ever-expanding global market.
4. If the speaker request is accepted, the sponsoring organization is put in direct contact with the confirmed speaker to discuss applicable session logistics.

What is the timeframe for approval?
	We aim to provide timely responses. But in some cases, the clearance process might take six weeks or longer once all the required information is submitted.

Who should use this form?
	Trade associations and industry groups that are requesting more than one speaker from FDA to participate at a single event or if the request involves more than one FDA-regulated product, please submit via the FDA Speaker Questionnaire.



For a speaker request to an event that pertains to only one FDA-regulated product, please select the best topic below, and then use the contact information to inquire directly with that FDA-regulated product area. Someone from that product area will provide further guidance regarding speaker request that involves only one FDA-regulated product area.

Topic
			Contact InformationAnimal & Veterinary
			AskCVM@fda.hhs.govBiologics, Blood, and Vaccines
			CBERSpeakerLiaison@fda.hhs.govCosmetics
			CFSANExecSec@fda.hhs.govDietary Supplements
			CFSANExecSec@fda.hhs.govDrugs
			CDERSpeakerRequests@fda.hhs.govFoods
			CFSANExecSec@fda.hhs.govMedical Devices
			CDRHSpeakerLiaison@fda.hhs.govRadiation-Emitting Products
			CDRHSpeakerLiaison@fda.hhs.govTobacco Products
			AskCTP@fda.hhs.govInspections and Enforcements
			ORAAppearances@fda.hhs.govFor any other FDA regulated product not listed above including the Office of the Commissioner activities, Email: FDASpeaks@fda.hhs.gov.

Can FDA guarantee that a speaker will be available?
	No, there is no guarantee that FDA will be able to provide a speaker for your event.

If I know the speaker, then can I contact him/her directly?
	No. That would delay your request. Please use the FDA Speaker Questionnaire rather than contacting the speakers directly.

How should invited FDA speakers be listed on electronic and hardcopy promotional materials (i.e., agendas, websites, brochures, emails)?
	Although FDA carefully considers each request for a speaker, every year we receive more requests than we can accept. While your request is pending, we would prefer that the promotional materials for your meeting simply state "FDA Invited" without mentioning the invited speaker by name. Once we have confirmed our participation, you may go ahead and name the confirmed speaker in your promotional materials.

How are speaker requests from FDA's foreign regulatory counterparts (including from World Health Organization/Pan American Health Organization (WHO/PAHO) officials handled?
	Our Office of Global Policy and Strategy handles all activities involving our foreign regulatory counterparts as well as WHO/PAHO officials. For information, please contact our Office of Global Policy and Strategy.

Who within FDA handles speaker requests from federal, state and local governments?
	Our Office of Partnerships/Office of Regulatory Affairs handles all our activities involving our federal, state and local officials. For more information, please contact our Office of Partnerships/Office of Regulatory Affairs.

Where can I send feedback?
	Please email any feedback to the Stakeholder Engagement Staff/Office of External Affairs/Office of the Commissioner at FDASpeaks@fda.hhs.gov.

                                                                                  Content current as of:
      10/15/2021FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
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