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Biologics, Blood & Vaccines Biologics, Blood & Vaccines Guidance, Compliance & Regulatory Information Acts, Rules & Regulations Guidances Establishment Registration Compliance Activities Enforcement Post-Market Activities Imports & Exports
The Industry page refers to both the “Manufacturers Assistance Branch” and the “Manufacturers Assistance and Technical Training Branch”. I didn’t know which name was current, so I used the shorter of the two in this wireframe.
Biologics, Blood & Vaccines
The Manufacturers Assistance Branch can answer questions on many policy and procedural topics including: o Information on clinical investigators 1 o How to report an adverse event o How to submit an application online (electronic submission) o How to submit an Investigational New Drug Application (IND) to administer an investigational product to humans
Industry
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These are the same general phone numbers shown in the Contact Us module. Are there more specific numbers to use? Is the e-mail address an individual’s name or an acronym for the Manufacturers Assistance and Technical Training Branch? If the latter, can it be in all CAPS, so it will look more like an acronym?
We answer questions and provide training to: o Large and small manufacturers o Trade associations
Acts, Rules & Regulations Public Health Service Act
Contact Us 800-835-4709 301-827-1800
Rules Comprehensive List of Laws Enforced
Guidances & SOPs
Consumers & Healthcare Providers
Email Page
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Code of Federal Regulations – Biologics Enforced
Resources for You
The page now has an announcement for a training program that closed on February 21. I did not include this announcement in this wireframe.
Guidance, Compliance & Regulatory Information
Please contact us: o Phone: 800-835-4709 or 301-827-1800 o E-mail:
[email protected]
This is a rewrite of the text on the Industry page: http://www.fda.gov/cber/ manufacturer.htm.
Guidances by Topic & Year Manual of SOPs
Imports & Exports
[email protected] Center for Biologics Evaluation and Research 1401 Rockville Pike, Suite 200N Rockville, MD 20852-1448
Media Inquiries About CBER
Compliance Program Guidance Manual – Imported CBER-Regulated Products Export Certificates Importing Samples for Research Use Only
Other Topics Compliance Activities Enforcement Post-Market Activities
Page Last Reviewed: Page Last Updated: Content Source: FDA Footer Rewrite of Manufacturers Page
Project: Prepared By:
FDA Template Wireframes Cari A. Wolfson, Focus on U!
Date Modified:
11/5/2008 by Design for
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