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FDA
Requirements for Packaging and Labeling
EU Guidances (Day
1 cont.)
- Checklist for Container Labeling for Marketed Prescription
Drug Products
- Requirements for Labels of Immediate Container & Cartons
- Drugs for Oral Use
- Checklist for Requirements for Rx Drug Labeling
- CDER Key Officials July 2004
- DDMAC Organization Listing-
Office of Medical Policy, Div. of Drug Marketing, Advertising,
and Communications (DDMAC), April 28, 2004
- DDMAC Contacts – Management & Administrative
Staff-office of Medical Policy, Div. of Drug Marketing,
Advertising, and Communications (DDMAC), April 26, 2004
- DDMAC Review http://www.fda.gov/cder/handbook/ppreview.htm
- Form FDA 2253 (10/01) Transmittal of Advertisements and
Promotional Labeling for Drugs and Biologics for Human
Use
- Guidance for Industry – Accelerated Approval Products – Submission
of Promotional Materials, Draft Guidance, March 1999
- Guidance for Industry – Product Name Placement,
Size, and Prominence in Advertising and Promotional Labeling,
Draft Guidance, January 1999
- Advertising/Labeling Definitions http://www.fda.gov/cder/handbook/adverdef.htm
- Guidance for Industry – Providing Regulatory Submissions
in Electronic Format – Content of Labeling, Draft
Guidance, February 2004
- Important Correction of Drug Information 21 CFR Ch. 1
(4-1-01 Edition) §200.7 <click
here for day 2>
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