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CDER NEWS |
April 9,
2010
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BPCA/Pediatric
Exclusivity
Statistics:
-
Guidance
for
Industry:
Q4B
Evaluation
and
Recommendation
of
Pharmacopoeial
Texts
for Use
in the
ICH
Regions
-
Listing
of OTC
Active
Ingredients
April 8,
2010
April 7,
2010
April 6,
2010
April 5,
2010
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April 8, 2010
- Bupropion Hydrochloride Extended-Release Tablets, Sun Pharmaceutical Industries, Inc., Approval
- Catapres (clonidine hydrochloride) Tablets, Boehringer Ingelheim, Labeling Revision
- Cetirizine Hydrochloride Capsules, Banner Pharmacaps, Inc., Manufacturirng Change or Addition
- Losartan Potassium and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Approval
- Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Approval
- Losartan Potassium Tablets, Upsher-Smith Laboratories, Inc., Tentative Approval
April 7, 2010
April 6, 2010
- Albuterol Sulfate Inhalation Solution, Apotex Inc., Approval
- Cystadane (betaine anhydrous) Oral Solution, Rare Disease Therapeutics, Inc., Labeling Revision
- FeverAll (acetaminophen) Rectal Suppositories, Actavis Mid Atlantic LLC, Labeling Revision
- Levofloxacin Tablets, Sandoz, Inc., Tentative Approval
- OxyContin (oxycodone hydrochloride) Controlled-Release Tablets, Purdue Pharma L.P., Approval
- Suprane (desflurane) Liquid Inhalation, Baxter Healthcare Corporation, Labeling Revision
- Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Pharmaceuticals, Inc., Efficacy and Labeling Revision
April 5, 2010
- Amlodipine and Valsartan Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval
- Memantine Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Propylthiouracil Tablets, Dava Pharmaceuticals, Inc., Labeling Revision
- Tenofovir Disoproxil Fumarate Tablets, InvaGen Pharmaceuticals, Inc., Tentative Approval
- Toviaz (fesoterodine fumarate) Extended Release Tablets, Pfizer Global Research and Development, Labeling Revision
- Verelan PM (verapamil hydrochloride) Extended-Release Capsules, Elan Drug Delivery, Inc., Labeling Revision
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4th
Annual
FDA/DIA
Statistics
Forum,
April
19-21,
2010,
Bethesda,
MD.
Meeting
information
and
registration
-
2010
PDA/FDA
Pharmaceutical
Supply
Chain
Workshop
- Enough
Talk:
Let's
Find and
Implement
Solutions,
April
26-28,
2010,
Hyatt
Regency
Bethesda,
7400
Wisconsin
Ave, 1
Bethesda
Metro
Center,
Bethesda,
MD
20814.
Meeting
information
and
registration
-
Public Hearing on Expanded Access of Direct-Acting Antiviral Agents (DAAs) for the Treatment of Chronic Hepatitis C Infection in Patients with Unmet Medical Need, April 30, 2010, Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852. Meeting information
-
FDA and
PAT for
Pharma
Manufacturing:
FDA-Partnering
with
Industry;
a joint
FDA/URI
College
of
Pharmacy
conference,
Bethesda,
Maryland,
Hyatt
Regency
Bethesda,
May
11-12,
2010.
Meeting
information
and
registration
-
Preparation
for ICH
Steering
Committee
and
Expert
Working
Group
Meetings
in
Tallinn,
Estonia
to
provide
information
and
receive
comments
on the
International
Conference
on
Harmonization
(ICH) as
well as
the
upcoming
meetings
in
Tallinn,
Estonia,
Public
Meeting,
Wednesday,
May 5,
2010,
Rockville,
Maryland.
Meeting
information
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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
Espaρol
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CBER NEWS |
- Vaqta
Supplement update for Package Insert, Posted: 4/9/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Analyst (FCIP), OM/DPS/PSB, Posted: 4/9/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Supervisory Chemist, OVRR/DVRPA, Posted: 4/9/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Secretary, OD/IOD, Posted: 4/8/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Regulatory Information Specialist, Posted: 4/8/2010
- Background on Study Results of U.S. Academic Researchers
Update on Rotarix Vaccine, Posted: 4/8/2010
- Recombinate
Revised the package insert to include additional adverse events, Posted: 4/7/2010
- Recall of AMICUS Ancillary PL2410 Plastic Storage Container 4R2350
Posted: 4/7/2010
- May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Posted: 4/7/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Consumer Safety Officer, OVRR/DBPAP, Posted: 4/7/2010
- Clinical Investigator Status (Biologics)
Quarterly update of Clinical Investigator Inspection List as of 3/11/2010, Posted: 4/6/2010
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Supervisory Mathematical Statistician, OBE, Posted: 4/6/2010
- TachoSil
Product Approval, Posted: 4/5/2010
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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.
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RULES - NONE |
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NOTICES
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Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Procedures for Safe and Sanitary Processing and
Importing of Fish and
Fishery Products
1821118213 [20108051]
[TEXT] [PDF]
Threshold of Regulation for Substances Used in
Food-Contact Articles
1820918210 [20108050]
[TEXT] [PDF]
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
MOZOBIL
18213 [20108172]
[TEXT] [PDF]
Public Educational Forum:
Drug and Medical Device Forum on Food and Drug
Administration Drug and
Device Requirements and
Supplier Controls
18219 [20108087]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Applications for Food and Drug Administration Approval
to Market a New Drug, etc.
1792417925 [20107891]
[TEXT] [PDF]
Recordkeeping Requirements for Microbiological Testing
and Corrective Measures for
Bottled Water
1792317924 [20107948]
[TEXT] [PDF]
Debarment Order:
Kevin Xu
1792717928 [20108023]
[TEXT] [PDF]
Filing of Food Additive
Petition:
Nisso America, Inc.
1792817929 [20107955]
[TEXT] [PDF]
Meetings:
Vaccines and Related Biological Products Advisory
Committee
17929 [20108025]
[TEXT] [PDF]
Withdrawal of Color Additive
Petition:
EMD Chemicals, Inc.
1793917940 [20107956]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES - NONE |
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RULES - NONE |
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NOTICES |
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
FANAPT
1741517416 [20107678]
[TEXT] [PDF]
TOVIAZ
1741417415 [20107679]
[TEXT] [PDF]
Meetings:
Arthritis Advisory Committee and the Drug Safety and
Risk Management Advisory
Committee; Amendment
17417 [20107697]
[TEXT] [PDF]
Peripheral and Central Nervous System Drugs Advisory
Committee
1741717418 [20107698]
[TEXT] [PDF]
Memorandum of Understanding:
Food and Drug Administration, Department of Health and
Human Services, and
Association of Minority
Health Profession Schools,
Inc.
1742317428 [20107677]
[TEXT] [PDF]
Food and Drug Administration, Department of Health and
Human Services, and National
Alliance for Hispanic Health
1741817423 [20107673]
[TEXT] [PDF]
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RULES - NONE |
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PROPOSED
RULES |
Neurological and Physical
Medicine Devices:
Designation of Special Controls for Certain Class II
Devices and Exemption From
Premarket Notification
1709317099 [20107637]
[TEXT] [PDF]
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NOTICES |
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
LUSEDRA
1714217143 [20107516]
[TEXT] [PDF]
Draft Guidance for Industry
and Food and Drug
Administration Staff:
Medical Devices; Neurological and Physical Medicine
Device Guidance Documents;
Availability
1714317145 [20107634]
[TEXT] [PDF]
Food Additives:
Bisphenol A; Availability
1714517147 [20107511]
[TEXT] [PDF]
International Conference on
Harmonisation:
Guidance on Q4B Evaluation and Recommendation of
Pharmacopoeial Texts, etc.;
Annex 7 on Dissolution Test
General Chapter
1714817149 [20107593]
[TEXT] [PDF]
Guidance on Q4B Evaluation and Recommendation of
Pharmacopoeial Texts, etc.;
Annex 9 on Tablet Friability
General Chapter
1714717148 [20107592]
[TEXT] [PDF]
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