81 FR 59635 - FDA Small Business and Industry Assistance Regulatory Education for Industry Fall Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 168 (August 30, 2016)

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) are sponsoring a 2 day conference entitled ``FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Fall Conference.'' The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. However, anyone involved in the pharmaceutical and/device industry may attend.

[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59635-59636]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


FDA Small Business and Industry Assistance Regulatory Education 
for Industry Fall Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of conference.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) and the Center for Devices and 
Radiological Health (CDRH) are sponsoring a 2 day conference entitled 
``FDA Small Business and Industry Assistance Regulatory Education for 
Industry (REdI) Fall Conference.'' The goal of this conference is to 
provide direct, relevant, and helpful information on the key aspects of 
drug and device regulations. Our primary audience is that of small 
manufacturers of drug and/or device medical products who want to learn 
about how FDA approaches the regulation of drugs and devices. However, 
anyone involved in the pharmaceutical and/device industry may attend.

DATES: The public conference will be held on September 27 and 28, 2016, 
from 8:15 a.m. to 4:15 p.m. See the SUPPLEMENTARY INFORMATION section 
for registration information.

ADDRESSES: The public conference will be held at the Sheraton Silver 
Spring Hotel, 8777 Georgia Ave., Cypress and Magnolia Ballrooms (4th 
floor), Silver Spring, MD 20910.

FOR FURTHER INFORMATION CONTACT: Brenda Stodart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6707, 
[email protected]; or Elias Mallis, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-7100, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public conference entitled ``FDA Small Business 
and Industry Assistance Regulatory Education for Industry (REdI) Fall 
Conference.'' This conference is intended to increase the drug and 
device industry's awareness of applicable FDA regulations. There will 
be an opportunity for questions and answers following each 
presentation.

[[Page 59636]]

II. Topics for Discussion at the Conference

     CDER: Manufacturing Process Validation; Interactions with 
FDA; Emerging Technology and Inspection for New Drug Applications and 
Biologic License Applications.
     CDRH: 510(k); De Novo; Design Controls; and Complaints.
    Registration: There is no fee to attend the public conference. 
Space is limited, and registration will be on a first-come, first-
served basis. To register, please complete registration at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm514324.htm.
    If you need special accommodations due to disability, please 
contact [email protected] at least 7 days in advance.
    Streaming Webcast of the Conference: This public conference will 
also be Webcast. Persons interested in viewing the Webcast must 
register to receive a confirmation email with the Webcast link.
    Transcripts: Transcripts will not be available.

    Dated: August 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20764 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P