September 4,
2009
September 3, 2009
September 2,
2009
September 1,
2009
-
Guidance for
Industry: Newly
finalized
Bioequivalence
Guidance:
Tacrolimus
August 31,
2009
Drug Approvals
September
3, 2009
September
2, 2009
-
Astepro
(azelastine
hydrochloride)
Nasal
Spray,
MEDA
Pharmaceuticals,
Approval
-
Benztropine
Mesylate
Injection,
Hikma
Farmaceutica
(Portugal),
S.A.,
Approval
-
Heparin
Sodium
Injection,
Hospira
Inc.,
Approval
-
Ibuprofen
Oral
Suspension,
Tris
Pharma,
Inc.,
Approval
-
Irbesartan
Tablets,
Cipla
Ltd.,
Tentative
Approval
-
Norethindrone
Acetate,
Ethinyl
Estradiol
and
Ferrous
Fumarate
(ethinyl
estradiol
and
norethindrone
acetate)
Tablets,
Watson
Laboratories,
Inc.,
Approval
-
Oxycodone
Hydrochloride
Tablets,
Avanthi,
Inc.,
Approval
September
1, 2009
-
Bicalutamide
Tablets,
Actavis
Totowa
LLC,
Approval
-
Carbamazepine
Extended-Release
Tablets,
Taro
Pharmaceutical
Industries
Ltd.,
Approval
-
Cephalexin
for
Oral
Suspension,
Hikma
Pharmaceuticals,
Approval
-
Levonorgestrel
Tablets,
Watson
Laboratories,
Inc.,
Approval
-
Valcyte
(valganciclovir
hydrochloride)
Oral
Solution,
Hoffmann-La
Roche,
Inc.,
Approval
Meetings
-
FDA,
Issues
in
the
Development
of
Antiviral
Products
for
Treatment
of
Smallpox
and
Related
Poxvirus
Infections;
Public
Workshop,
September
1-2,
2009
-
2009
PDA/FDA
Joint
Regulatory
Conference,
September
14-18,
2009,
Renaissance
Hotel,
999
9th
Street
NW,
Washington,
D.C.
Meeting
Information
and
registration
-
Drug
Information
Association
(DIA)
and
Food
and
Drug
Administration
(FDA):
Cardiovascular
Safety
and
Development
of
Type
2
Diabetes
Mellitus
Medications:
Current
State
of
the
Art
and
Opportunities
to
Advance
the
Science,
September
23-24,
2009,
Omni
Shoreham
Hotel,
Washington,
DC.
Meeting
Information
and
registration
-
Educating
the
Public
About
Removal
of
Essential-Use
Designation
for
Epinephrine,
Public
Workshop,
September
25,
2009,
FDA,
Center
for
Drug
Evaluation
and
Research
Advisory
Committee
Conference
Room,
5600
Fishers
Lane,
Rm
1066,
Rockville,
Maryland
20852
-
Providing
Effective
Information
to
Consumers
about
Prescription
Drug
Risks
and
Benefits;
Public
Workshop,
September
24-25,
2009,
Gaithersburg,
MD
20877.
Meeting
Information
-
CDER
Forum
for
International
Drug
Regulatory
Authorities,
October
5-9,
2009,
Silver
Spring,
Maryland.
CDER
Drug Links
|
2009 Meeting Materials, Vaccines and
Related Biological Products Advisory
Committee
9/9/2009 Advisory
Committee Meeting Briefing
Information, Posted: 9/4/2009
Influenza Virus Vaccine Actions
Posted: 9/3/2009
Jobs at the Center for Biologics
Evaluation and Research (CBER)
Administrative Support
Clerk/Assistant (OA), Posted:
9/3/2009
Blood Establishment Computer
Software: Understanding What to
Include in a 510(k) Submission;
Public Workshop
Posted:
9/3/2009
Jobs at the Center for Biologics
Evaluation and Research (CBER)
Medical Officer (OVRR), Posted:
9/2/2009
Influenza Virus Vaccine for the
2009-2010 Season
Lot
Release Information, Updated:
9/2/2009
Jobs at the Center for Biologics
Evaluation and Research (CBER)
Medical Officer/Lead /Supv MO-
Direct Hire (COSTA RICO), Posted:
9/1/2009
Biologics PREA Labeling Changes
Updated: 8/31/2009
Guidance for Industry -
Recommendations for Management of
Donors at Increased Risk for Human
Immunodeficiency Virus Type 1
(HIV-1) Group O Infection
Posted: 8/31/2009
Jobs at the Center for Biologics
Evaluation and Research (CBER)
Biostatistics Fellowship (OBE),
Posted: 8/31/2009
CBER
Meetings
- 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.
|
September 4, 2009
- Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; TALENT ABDOMINAL STENT GRAFT SYSTEM
September 2, 2009
- Follow Us on Twitter
September 1, 2009
- PMA Final Decisions for July 2009
August 31, 2009
- Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
CDRH
Workshops
and
Meetings
- FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, June 1-2, 2009
- FDA Workshop: Implementation of Post Approval Studies for Medical Devices, June 4-5, 2009
- Introduction to Medical Device Research and Making the Risk Determination, June 17, 2009
- FDA Workshop: Methodologies for Post-Approval Studies of Medical Devices, September 9-10, 2009
- Center for Devices and Radiological Health Forum for International Medical Device Regulatory Authorities, September 14-16, 2009
- 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009
- FDA Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes, October 29-30, 2009
- FDA Workshop: Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections, November 12-13, 2009
|
|
This
Week
Rule Changes:
21 CFR Parts
16 and 118 |
|
Friday, Sept. 04, 2009
|
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
4585845859 [E921364]
[TEXT] [PDF]
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
BANZEL
4586445865 [E921428]
[TEXT] [PDF]
DORIBAX
4586345864 [E921365]
[TEXT] [PDF]
Talent Abdominal Stent Graft System
4586545866 [E921424]
[TEXT] [PDF]
Report on the Performance of
Drug and Biologics Firms in
Conducting Postmarketing
Requirements and
Commitments; Availability
4586745872 [E921302]
[TEXT] [PDF]
|
|
Thursday,
Sept. 03, 2009 |
NONE
|
|
Wednesday,
Sept. 02, 2009 |
|
NONE
|
|
Tuesday,
Sept. 01, 2009 |
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
4521645219 [E921026]
[TEXT] [PDF]
45221 [E921097]
[TEXT] [PDF]
4521945221 [E921099]
[TEXT] [PDF]
Guidance for Industry:
Labeling of
Nonprescription Human Drug
Products, etc.
4522245223 [E921093]
[TEXT] [PDF]
Questions
and Answers Regarding the
Labeling of Dietary
Supplements, etc.
4522145222 [E921094]
[TEXT] [PDF]
Patent Extensions:
TAPENTADOL
HYDROCHLORIDE
4522545226 [E921100]
[TEXT] [PDF]
|
|
Monday,
August 31, 2009 |
|
RULES
Egg Safety:
Prevention of Salmonella
Enteritidis in Shell Eggs
During Production, Storage,
and Transportation; Public
Meetings,
4475044751 [E920856]
[TEXT] [PDF]
NOTICES
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
44855 [E920895]
[TEXT] [PDF]
|
|
|
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