August
14, 2009
August
13, 2009
August
12, 2009
August
11, 2009
August
10, 2009
Drug Approvals
August
13, 2009
-
- Clindamycin Phosphate and Benzoyl Peroxide Gel, Dow Pharmaceutical Sciences, Inc., Approval
- Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Laboratories Ltd., Tentative Approval
- Mitomycin, Injection, Accord Healthcare, Inc., Labeling Revision
- Ofloxacin Otic Solution, PharmaForce, Inc., Approval
- Renvela (sevelamer carbonate) Oral Powder, Genzyme Corp., Approval
August
12, 2009
-
- Sertraline Hydrochloride Tablets, Hikma Pharmaceuticals, Approval
- Sumatriptan Succinate Tablets, Orchid Healthcare, Approval
- Sumatriptan Succinate Tablets, Aurobindo Pharma Limited, Approval
- Sumatriptan Succinate Tablets, Sun Pharmaceuticals, Approval
- Sumatriptan Succinate Tablets, Orchid Healthcare, Approval
- Sumatriptan Succinate Tablets, Roxane Laboratories Inc., Approval
- Sumatriptan Succinate Tablets, Mylan Pharmaceuticals Inc., Approval
- Sumatriptan Succinate Tablets, Ranbaxy Laboratories Ltd., Approval
- Sumatriptan Succinate Tablets, GlaxoSmithKline, Approval
- Sumatriptan Succinate Tablets, Dr. Reddy's Laboratories Ltd., Approval
- Sumatriptan Succinate Tablets, Cobalt Laboratories, Inc., Approval
- Tacrolimus Capsules, Sandoz Inc., Approval
August
11, 2009
-
- Oxaliplatin Injection, Mustafa Nevsat Ilac Sanayii A.S., Tentative Approval
- Oxaliplatin I.V. Injection, Fresenius Kabi Oncology Plc., Approval
- Oxaliplatin I.V. Injection, EBEWE Pharma, Approval
- Oxaliplatin I.V. Injection, Hospira Worldwide PTY, Tentative Approval
- Oxaliplatin I.V. Injection, Sun Pharma Global, Approval
- Tracleer (bosentan) Tablets, Actelion Clinical Research, Inc., Supplement
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
-
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,
MD.
CDER
Drug Links
|
- 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.
|
|
|
This
Week
Rule Changes:
21 CFR Parts
2
-
312 -
316 - 558 |
|
Friday,
August
14, 2009 |
NOTICES
Draft
Guidance on Q4B Evaluation
and Recommendation of
Pharmacopoeial Texts, etc.:
Annex 10
on Polyacrylamide Gel
Electrophoresis General
Chapter; Availability
4114341144 [E919522]
[TEXT] [PDF]
Draft Guidance on Q4B
Evaluation and
Recommendation of
Pharmacopoeial Texts, etc.:
International Conference on Harmonisation
4114441145 [E919528]
[TEXT] [PDF]
|
|
Thursday,
August
13, 2009 |
RULES
Charging
for Investigational Drugs
Under an Investigational New
Drug Application
4087240900 [E919004]
[TEXT] [PDF]
Expanded
Access to Investigational
Drugs for Treatment Use
4090040945 [E919005]
[TEXT] [PDF]
New Animal
Drugs for Use in Animal
Feeds:
Oxytetracycline; Neomycin
4072340726 [E919414]
[TEXT] [PDF]
|
|
Wednesday,
August 12, 2009 |
|
NONE
|
|
Tuesday,
August 11, 2009 |
RULES
Use of
Ozone-Depleting Substances;
Epinephrine; CFR Correction
40069 [E919297]
[TEXT] [PDF]
NOTICES
Determination of
Regulatory Review Period for
Purposes of Patent
Extension:
NPLATE
4020540206 [E919233]
[TEXT] [PDF]
Meetings:
Joint Meeting of the Anesthetic and Life Support
Drugs Advisory Committee and
the Drug Safety and Risk
Management Advisory
Committee
40207 [E919105]
[TEXT] [PDF]
Oncologic Drugs Advisory Committee
4020940210 [E919106]
[TEXT] [PDF]
Review of
Post-Inspection Responses
4021140212 [E919107]
[TEXT] [PDF]
|
|
Monday,
August 10, 2009 |
|
NOTICES
Availability of Grant Funds:
Office of Critical Path
Programs; Critical Path
Initiative
3996339964 [E919010]
[TEXT] [PDF]
|
|
|
.jpg)
