Federal
Register Date: 03/20/97
Page No.: 13467
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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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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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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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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