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Food and Drug Adminstration (FDA): CDRHNew
Items added to the FDA's Center for Devices and Radiological Health website within the last month.Wednesday, May 19, 2010, 9:00:00 PM This draft guidance is intended to provide information on the implementation of a section of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends a section of the Federal Food, Drug, and Cosmetic Act (the act).
2) Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
Wednesday, April 28, 2010, 9:00:00 PM The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information respecting the class in which a device has been classified or the requirements applicable to a device under the Federal Food...
3) Draft Guidance for Industry and FDA Staff: User Fees for 513(g) Requests for Classification Information
Wednesday, April 28, 2010, 9:00:00 PM Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L. 110-85, extends FDA?s authority to collect medical device user fees by establishing a fee for...
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What's New at CDER
Adverse Event Reporting System (AERS) Statistics
Friday, May 21, 2010, 3:23:00 PM Four AERS summary statistics reports updated with data through March 31, 2010.
Friday, May 21, 2010, 4:53:00 AM Files updated for 3rd Quarter 2009.
Thursday, May 20, 2010, 9:51:00 AM Letters added
What's New: Vaccines, Blood & Biologics RSS Feed
Documents recently posted on the CBER Web Site
Regulatory Submissions in Electronic Format for Biologic Products
Monday, May 10, 2010, 7:54:00 PM FDA has started the transition to a more automated electronic review process for these submissions
Drug Master Files for CBER-Regulated Products
Tuesday, May 11, 2010, 11:31:00 AM Drug Master Files for CBER-Regulated