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CDER NEWS |
April 16, 2010
- FDA Issues the following Warning Letters:
- FDA Issues the following Letters:
- Medication Guides
April 13, 2010
April 12, 2010
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April 16, 2010
- Allegra-D 12 Hour (fexofenadine hydrochloride and pseudoephedrinie hydrochloride) Extended-Release Tablets, Sanofi-Aventis, Labeling Revision
- Allegra-D 24 Hour (fexofenadine hydrochloride and pseudoephedrinie hydrochloride) Extended-Release Tablets, Sanofi-Aventis, Labeling Revision
- Ambien CR (zolpidem tartrate) Extended-Release Tablets, Sanofi-Synthelabo Research, Labeling Revision
- Lamictal XR (lamotrigine) Extended-Release Tablets, GlaxoSmithKline, Manufacturing Change or Addition
- Memantine Hydrochloride Tablets, Reddy’s Laboratories Limited, Approval
- Ondansetron Hydrochloride Injection, Lannett Holdings, Inc., Approval
April 15, 2010
- Calan (verapamil hydrochloride) Tablets, Pfizer, Incorporated, Labeling Revision
- Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision
- Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision
- Covera HS (verapamil hydrochloride) Extended-Release Tablets, Pfizer, Incorporated, Labeling Revision
- Doral (quazepam) Tablets, Questcor Pharma., Inc., Labeling Revision
- Hydromorphone Hydrochloride Injection, Akorn, Inc., Approval
- Lidoderm (lidocaine) Patch, Teikoku Pharma USA, Inc., Labeling Revision
- Oraqix (lidocaine and prilocaine) Periodontal Gel, Dentsply Pharmaceutical, Inc., Labeling Revision
- Ortho Evra (norelgestromin and ethinyl estradiol) Patch, Johnson & Johnson Pharmaceuticals Research, Labeling Revision
- Pancreaze (pancrelipase) Delayed-Release Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Approval
April 14, 2010
- Anthelios 40 (ecamsule, avobenzone, octocrylene, and titanium dioxide) Cream, L’Oreal Products, Inc., Labeling Revision
- Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser Inc., Labeling Revision
- Didanosine Delayed-Release Capsules, Matrix Laboratories Limited, Approval
- Donepezil Hydrochloride Orally Disintegrating Tablets, Barr Laboratories, Inc., Tentative Approval
- Granisetron Hydrochloride Injection, Sagent Strides, Approval
- Pramipexole Dihydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval
- Uroxatral (alfuzosin hydrochloride) Extended-Release Tablets, sanofi-aventis U.S., LLC, Labeling Revision
- Venlafaxine Hydrochloride Tablets, Auroblndo Pharma Limited, Approval
- Yasmin (drospirenone and ethinyl estradiol) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Yaz (drospirenone and ethinyl estradiol) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision
April 13, 2010
- Gyne-Lotrimin (clotrimazole) Vaginal Cream, Schering-Plough HealthCare Products, Inc., Labeling Revision
- Gyne-Lotrimin 3 (clotrimazole) Vaginal Cream, Schering-Plough HealthCare Products, Inc., Labeling Revision
- Losartan Potassium Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
- Ondansetron Orally Disintegrating Tablets, Aurobindo Pharma USA, Inc., Approval
- Tev-Tropin (somatropin [rDNA origin]), Injection, Ferring Pharmaceuticals, Inc., Labeling Revision
April 12, 2010
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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
-
FDA
Orphan
Drugs
Workshops,
August
3-4,
2010,
Minneapolis,
MN.
Meeting
Brochure
(PDF -
91 KB)
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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
Español
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CBER NEWS |
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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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CDRH NEWS |
April 15, 2010
April 13, 2010
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-
53rd Annual FDLI
Conference, April 22-23,
2010
-
Town Hall Discussion
With the Director of
CDRH and Other Senior
Center Management, May
18, 2010
-
CDRH Forum for
International Medical
Device Regulatory
Authorities, May 3-6,
2010
-
Medical Design &
Manufacturing (MD&M)
East Conference, June
7-10, 2010
-
FDA / NHLBI / NSF
Workshop on Computer
Methods for
Cardiovascular Devices,
June 10-11, 2010: The
integration of
nonclinical and computer
models
-
Drug Information
Association 46th Annual
Meeting, June 13-17,
2010
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Guidance Documents (Medical Devices)
How to Market Your Device
Postmarket Requirements (Devices)
Importing and Exporting Devices
International Information (Devices)
Device Classification
Bioresearch Monitoring
FDA eSubmitter
CDRH Learn |
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RULES - NONE |
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NOTICES
- NONE |
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Export of Medical Devices–Foreign Letters of Approval
19651–19652 [2010–8572]
[TEXT] [PDF]
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RULES |
Use of Ozone-Depleting
Substances; Removal of
Essential-Use Designation:
Flunisolide, etc.
19213–19241 [2010–8467]
[TEXT] [PDF]
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals:
Adoption of FDA Food Code by Local, State, and Tribal
Governments
19405–19406 [2010–8510]
[TEXT] [PDF]
Determination of Regulatory
Review Period for Purposes
of Patent Extension:
AFINITOR
19406–19407 [2010–8443]
[TEXT] [PDF]
Savella
19407 [2010–8518]
[TEXT] [PDF]
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RULES |
Prevention of Salmonella
Enteritidis in Shell Eggs
During Production, Storage,
and Transportation, etc.;
Technical Amendment
18751 [2010–8358]
[TEXT] [PDF]
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NOTICES |
Meetings:
International Conference on Harmonisation Steering
Committee and Expert Working
Group
18848 [2010–8379]
[TEXT] [PDF]
Public Workshop:
Computer Methods for Cardiovascular Devices;
Integration of Nonclinical
and Clinical Models
18849 [2010–8311]
[TEXT] [PDF]
Small Entity Compliance
Guide:
Prevention of Salmonella Enteritidis in Shell Eggs
During Production, Storage,
and Transportation;
Availability
18849–18850 [2010–8359]
[TEXT] [PDF]
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RULES - NONE |
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PROPOSED
RULES - NONE |
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NOTICES |
Draft Guidance for Industry:
Guidances for the Validation of Analytical Methods Used
in Residue Depletion
Studies; Availability
18505–18507 [2010–8230]
[TEXT] [PDF]
Draft Guidance for Industry;
Studies to Evaluate
Metabolism and Residue
Kinetics of Veterinary Drugs
in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals;
Availability
18507–18508 [2010–8229]
[TEXT] [PDF]
Marker Residue Depletion Studies to Establish Product
Withdrawal Periods;
Availability
18504–18505 [2010–8231]
[TEXT] [PDF]
Metabolism Study to Determine the Quantity and Identify
the Nature of Residues;
Availability
18508–18509 [2010–8228]
[TEXT] [PDF]
Guidance on Q4B Evaluation
and Recommendation of
Pharmacopoeial Texts for Use
in International Conference
on Harmonisation Regions:
Annex 10 on Polyacrylamide Gel Electrophoresis General
Chapter; Availability
18509–18510 [2010–8227]
[TEXT] [PDF]
Public Workshop; Request for
Comments:
Developing Guidance on Naming, Labeling, and Packaging
Practices to Reduce
Medication Errors
18514–18516 [2010–8233]
[TEXT] [PDF]
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