Center for Biologics Evaluation and Research

Notice: 2

Received: 8/7/06
Published in the Federal Register: 8/8/06 71FR45057
Submitter: CBER
Record Name(s): Electronic Gateway [ HTM] [ PDF ]
Effective Date: August 8, 2006

Memorandum: 26
Received: 8/8/03
Submitter: CBER
Record Name(s): Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Form FDA 3356) Cover Memo [Word] Attachment [PDF]
Regulatory Citation(s): 21 CFR 1271.22
Effective Date: August 8, 2003

Memorandum: 25
Received: 11/15/2002
Submitter: CBER
Record Name(s): Blood Establishment Registration and Product Listing (Form FDA 2830) Cover Memo [Word] [PDF] Attachment [PDF]
Regulatory Citation(s): 21 CFR 607.22
Effective Date: November 15, 2002

Memorandum: 22
Received: 05/22/2002
Submitter: CBER
Record Name(s): Postmarketing Expedited and periodic Individual Case Safety Reports (ICSRs only)  doc  
Regulatory Citation(s): 21 CFR 600.809c)
Effective Date: 06/03/2002

Memorandum: 21
Received: 05/22/2002
Submitter: CBER
Record Name(s): Investigational New Drug Applications
Cover Memo   doc   Attachment   pdf
Regulatory Citation(s): 21 CFR 312
Effective Date: 09/30/2002

Memorandum: 20
Received: 05/22/2002
Submitter: CBER
Record Name(s): Advertisements and Promotional Labeling
Cover Memo   doc   Attachment   pdf
Regulatory Citation(s): 21 CFR 601.12(f)(40 and 21 CFR 601.45
Effective Date: 07/30/2002

Memorandum: 8
Received: 12/20/1999
Submitter: CBER
Record Name(s): Biologics License Applications (BLA)
Product License Applications (PLA)
Establishment License Applications (ELA)
New Drug Applications (NDA)
Regulatory Citation(s): 21 CFR 601.2 and 21 CFR 314.50
Effective Date: 01/01/1999

Supplement: 1
Received: 02/04/2000
Submitter: CBER
Record Name(s): Biologics License Applications (BLA)
Product License Applications (PLA)
Establishment License Applications (ELA)
New Drug Applications (NDA)
Regulatory Citation(s): 21 CFR 601.2 and 21 CFR 314.50
Effective Date: 06/01/2000

Memorandum: 9
Received: 02/04/2000
Submitter: CBER
Record Name(s): Biologics Market
Regulatory Citation(s): 21 CFR 601.2 and 21 CFR 314.50
Effective Date: 01/01/1999

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Center for Drug Evaluation and Research

Memorandum: 33
Received: September 13, 2007
Submitter: CDER
Record Name(s): Investigational New Drug Applications, New Drug Applications, Biologics Licensing Applications, Abbreviated New Drug Applications, Master Files, Annual Reports
Regulatory Citations(s): 21 CFR 312; 21 CFR 314; 21 CFR 600
Effective Date: January 1, 2008

Memorandum: 32
Received: October 21, 2005
Submitter: CDER
Record Name(s): Content Labeling   pdf
Regulatory Citation(s): 314.50(l), 314.94(d), 601.14(b), and 314.81(b)
Effective Date: October 31, 2005

Memorandum: 31
Received: September 21, 2004
Submitter: CDER
Record Name(s): Content Labeling   pdf, See Memorandum 32
Regulatory Citation(s): 314.50(l), 314.94(d), 601.14(b), and 314.81(b)
Effective Date: September 24, 2004

Memorandum: 30
Received: March 31, 2004
Submitter: CDER
Record Name(s): New Drug Applications - Annual Reports; Abbreviated New Drug Applications - Annual Reports  pdf
Regulatory Citation(s):
Effective Date: April 1, 2004

Memorandum: 28
Received: September 24, 2003
Submitter: CDER
Record Name(s): Postmarketing Expedited and Periodic Individual Case Safety Reports including descriptive material   pdf;   See Memorandum 23
Regulatory Citation(s): 21 CFR 310.305(c); 314.80(c), 600.80(o)
Effective Date: September 24, 2003

Memorandum: 27
Received: August 27, /2003
Submitter: CDER
Record Name(s): Investigational New Drug Applications, New Drug Applications, Abbreviated New Drug Applications, Master Files, Annual Reports, Promotional material   pdf  
Regulatory Citation(s): 21 CFR 312; 21 CFR 314
Effective Date: September 1, 2003

Memorandum: 24
Received: July 09, 2002
Submitter: CDER
Record Name(s): Abbreviated New Drug Applications (ANDA) cover letter   doc   part 2   pdf
Regulatory Citation(s): 21 CFR 314.94
Effective Date: July 12, 2002

Memorandum: 23
Received: June 3, 2002
Submitter: CDER
Record Name(s): Postmarketing Expedited and Periodic Individual Case Safety Reports (ICSRs only) pdf  Supercedes Memorandum 15
Regulatory Citation(s): 21 CFR 314.305(c), 314.80(c), 314.98, 600.80(c)
Effective Date: May 22, 2002

Memorandum:17 
Received: February 12, 2002
Submitter: CDER
Record Name: Advertisements and Promotional Labeling  Cover Letter (M18)  [pdf]  [Word] Part 2 [pdf]
Regulatory Citation: 21 CFR 314.81(b)(3)(i)
Effective Date: February 8, 2002

Memorandum:16  
Received: November 28, 2001
Submitter: CDER
Record Name: Withdraws Memorandum: 12  Postmarketing Expedited Safety Reports - 15-Day Alert Reports   [Word version]
Regulatory Citation: 21 CFR 310.305(c), 314.80(c)(1), 314.98 and 600.80(c)(1)
Effective Date: November 28, 2001

Memorandum:15    
Received: November 28, 2001
Submitter: CDER
Record Name: Postmarketing Expedited and Periodic ICSRs  superceded by Memorandum 23 pdf 
Regulatory Citation: 21 CFR 310.305(c), 314.80(c), 314.98 and 600.80(c)
Effective Date: November 29, 2001

Memorandum:7
Received: January 29, 1999
Submitter: CDER
Record Name: Withdrawal of Memos 2 and 3
Regulatory Citation:
Effective Date: February 2, 1999

Memorandum: 6
Received: January 29, 1999
Submitter: CDER
Record Name: New Drug Application Submissions
Regulatory Citation: 21 CFR 314.50
Effective Date: February 1, 1999

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Center for Food Safety and Applied Nutrition

Memorandum: 19
Received: February 27, 2002
Submitter: CFSAN
Record Name: Food and Color Additive Petitions
Regulatory Citation: 21 CFR 71 and 171.1
Effective Date: February 27, 2002

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Center for Veterinary Medicine

Memorandum: 14  pdf   doc
Received:  July 10, 2001
Submitter:  CVM
Record Name: Guidance for Industry (#59): Submitting A Notice Of Claimed Investigational Exemption In Electronic Format To The Center For Veterinary medicine Via E-Mail   pdf   doc
Effective Date: June 26, 2001

Memorandum: 13
Received:  May 25, 2001
Submitter:  CVM
Record Name: (1) Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations, and (2) Guidance for Industry: Providing Regulatory Submissions in Electronic Format - NDA  PDF

Memorandum: 11
Received:  February 28, 2001
Submitter:  CVM
Record Name: Final Disposition of Slaughter for Human Food Purposes  PDF, WORD
Regulatory Citation(s): CFR 11.2(b)(2)

Memorandum: 10
Received:  February 28, 2001
Submitter:  CVM
Record Name: Final Disposition of Animals not Intended for Immediate Slaughter & A request for a meeting or teleconference to the Office of New Animal Drug Evaluation (ONADE) at the Center for Veterinary Medicine (CVM or the Center). Effective date: 2/16/2001  PDF, WORD
Regulatory Citation(s): CFR 11.2(b)(2)

Memorandum: 4
Received: January 22, 1999
Submitter: CVM
Record Name: Basic Information Regarding Submission of Notices of Claimed Investigational Exemption to Center for Veterinary Medicine

Memorandum: 4
Received: March 6, 1998
Submitter: CVM
Record Name: Basic Information Regarding Submission of Notices of Claimed Investigational Exemption to Center for Veterinary Medicine, Extension

Memorandum: 1
Received: September 3, 1997
Submitter: CVM
Record Name: Basic Information Regarding Submission of Notices of Claimed Investigational Exemption to Center for Veterinary Medicine

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Office of Regulatory Affairs

Memorandum: 29
Received: September 30, 2003
Submitter: ORA
Record Name(s): New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) cover letter   pdf   part 2   pdf
Regulatory Citation(s): 21 CFR 314.440(a)(4)
Effective Date: October 1, 2003

Office of Orphan Products Development

Memorandum: 33
Received: April 6, 2006
Submitter: Orphan Products Development
Record Name(s): Orphan-Drug Designation Requests, Humanitarian Use Device Designation Requests, and Related Submissions - correspondence, annual reports, amendments   pdf
Regulatory Citation(s): 21 CFR 316 and 814
Effective Date: April 1, 2006

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Page last updated October 2, 2007