|
|
December 31, 2009
December 29, 2009
December 28, 2009
|
|
|
December 30, 2009
- Arixtra (fondaparinux sodium) Subcutaneous Injection, GlaxoSmithKline, Labeling Revision
- Atomoxetine Hydrochloride, Capsules, Glenmark Generics Ltd., Tentative Approval
- Fragmin (dalteparin sodium) Subcutaneous Injection, Eisai Inc., Labeling Revision
- Innohep (tinzaparin sodium) Injection, Celgene Corp., Labeling Revision
- Lexiscan (regadenoson) Intravenous Solution, Astellas Pharma US, Inc., Labeling Revision
- Lovenox (enoxaparin sodium) Subcutaneous Injection, Sanofi-Aventis, Labeling Revision
|
|
|
-
FDA
Orphan
Drugs
Workshops,
February
25-26,
2010,
Claremont,
CA;
August
3-4,
2010,
Minneapolis,
MN.
Meeting
Brochure
(PDF -
91 KB)
-
Indexing
Labeling
for
Human
Drug and
Biological
Products
using
Structured
Product
Labeling
(SPL).
February
2010.
-
FDA/DIA
5th
Workshop
in a
Series
on
Pharmacogenomics:
Generating
and
Weighing
Evidence
in Drug
Development
and
Regulatory
Decision
Making,
February
2-4,
2010,
Marriott
Bethesda
North
Hotel
and
Conference
Center,
5701
Marinelli
Road,
Bethesda,
MD.
Meeting
Information
and
registration
-
DIA/FDA
CDER/CBER
Computational
Science
Annual
Meeting,
March
22-23,
2010,
Bethesda,
MD.
Meeting
information
and
registration.
-
4th
Annual
FDA/DIA
Statistics
Forum,
April
19-21,
2010,
Bethesda,
MD.
Meeting
information
and
registration.
|
|
|
|
Guidance
Approved Drugs
Approval Process
Electronic Submissions
Firm Registration Status
Good Manufacturing Practice
Regulations
National Drug Code Directory
MedWatch: Adverse Event
Reporting
Download Forms
Generic Drugs
Small Business
En
Español
|
|
|
|
- Approval History, Letters, Reviews, and Related Documents - Wilate
Wilate, von Willebrand Factor/Factor VIII Concentrate (Human), Posted: 12/31/2009
- Havrix
12/14/2009 Approval Letter, Package Insert updated to include additional adverse events. Updated: 12/31/2009
- Engerix-B
12/23/2009 Approval Letter, Package Insert updated to include the addition of text to visually inspect vials or syringes for cracks prior to administration. Updated: 12/31/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot release information, Updated: 12/30/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot release information, Updated: 12/30/2009
- List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
Updated: 12/28/2009
- Approval History, Letters, Reviews, and Related Documents - Agriflu
Approval History, Letters, Reviews, and Related Documents, Updated: 12/24/2009
- Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 (PDF - 858KB)
A technical correction has been made to the “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated August 2009 with respect to the dosage and administration of platelet components. 10/2009, Updated: 12/2009
|
|
|
|
|
|
|
|
About CBER
CBER Vision & Mission
Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance
News & Events (Biologics)
What's New, Meetings & Workshops
CBER Reports
CBER Annual Report, Performance, FDAMA, PDUFA, FDAAA, PREA
Biologics Regulated Products
Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation
Contacts in the Center for Biologics Evaluation & Research (CBER)
Consumer questions, manufacturer's assistance, media inquiries, technical questions, requesting speakers, establishment registration...
Jobs at the Center for Biologics Evaluation and Research (CBER)
Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
Biologics Electronic Reading Room (eFOI)
Documents frequently requested through the Freedom of Information Act.
|
|
|
|
|
|
|
|
RULES
- NONE |
|
|
NOTICES
- NONE |
|
|
|
|
RULES
- NONE |
|
|
NOTICES
- NONE |
|
|
|
|
RULES
- NONE |
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
69106–69111 [E9–30872]
[TEXT] [PDF]
Meetings:
Advisory Committees; Tentative Schedule (for 2010)
69119–69122 [E9–30973]
[TEXT] [PDF]
Medical Device Interoperability; Public Workshop
69125–69126 [E9–30871]
[TEXT] [PDF]
Second Annual Sentinel Initiative Public Workshop
69122 [E9–30971]
[TEXT] [PDF]
|
|
|
|
PROPOSED RULES |
Informed Consent Elements
68750–68756 [E9–30751]
[TEXT] [PDF]
|
|
NOTICES |
Guidance to Pharmacies on
Advance Compounding of
Tamiflu Oral Suspension to
Provide for Multiple
Prescriptions; Availability
68845–68846 [E9–30750]
[TEXT] [PDF]
|
|
|
|
RULES |
New Animal Drugs; Change of
Sponsor:
Isoflurane
68529–68530 [E9–30590]
[TEXT] [PDF]
|
|
NOTICES |
Draft Guidance for Industry:
Tobacco Health Document Submission; Availability
68629 [E9–30657]
[TEXT] [PDF]
|
|
|
|
|
|
