|
|
|
Center
for Drug Evaluation &
Research (CDER) News
Drug Approvals -
Meetings
-
Links |
Center
for Biologics Evaluation
&
Research (CBER)
Meetings
-
Links |
Center
for Device &
Radiological
Health (CDRH)
Meetings
-
Links |
Federal Register -
Meetings, Notices, & Rule Changes |
|
|
February 13, 2010
February 12, 2010
February 11, 2010
February 8, 2010
|
|
|
|
|
|
|
- FDA Technical Briefing on Its FY 2011 Budget Request, Monday, February 1, 3:30 p.m. EST.
- 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
- AASLD/FDA/PhRMA Drug-Induced Liver Injury: Getting the Medicine and Science Together, March 24-25, 2010, Silver Spring, 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
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
-
The A to Z of Off Label
Issues, February 9, 2010
-
Public Meeting:
Incorporation of New
Science Into Regulatory
Decision-making Within
the Center for Devices
and Radiological Health
- February 9, 2010
-
510(k) Submissions - The
Course for Beginning RA
Professionals for
Preparing a 510(k),
February 22-23, 2010
-
Investigational Device
Exemption (IDE)
Submission Workshop,
February 24, 2010
-
PMA Submissions
Workshop, February
25-26, 2010
-
FDA/CDRH Public Meeting:
Blood Glucose Meters -
March 16-17, 2010
-
Forum for International
Medical Device
Regulatory Authorities,
May 3-6, 2010
|
|
|
|
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
|
|
|
|
|
|
|
RULES
- NONE |
|
|
NOTICES
- NONE |
|
|
|
|
RULES
- NONE |
|
|
NOTICES
- NONE |
|
|
|
|
RULES
- NONE |
|
|
NOTICES
- NONE |
|
|
|
|
RULES - NONE |
|
|
NOTICES |
Medical Devices Regulated by
the Center for Biologics
Evaluation and Research:
Availability of Summaries of Safety and Effectiveness
Data for Premarket Approval
Applications
6401–6402 [2010–2757]
[TEXT] [PDF]
Regulatory Site Visit
Training Program
6404 [2010–2758]
[TEXT] [PDF]
|
|
|
|
RULES
- NONE |
|
|
NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
6206–6207 [2010–2598]
[TEXT] [PDF]
Guidance for Industry and
Food and Drug
Administration:
Use of Bayesian Statistics in Medical Device Clinical
Trials; Availability
6209–6210 [2010–2596]
[TEXT] [PDF]
Guidance for Industry:
Contents of Complete Submission for Evaluation of
Proprietary Names;
Availability
6210–6211 [2010–2660]
[TEXT] [PDF]
|
|
|
|
|
|
|
|
-
February 12, 2010 -
U.S. Attorney News Release: Company pleads guilty to felony misbranding of a
drug
-
February 12, 2010 -
U.S. Attorney News Release: Subject sentenced to 51 months for sale of
unapproved medical devices
-
February 12, 2010 -
U.S. Attorney New Release: Business Owner Pleads Guilty to Fraudulently
Marketing Dietary Supplements
-
February 09, 2010 -
FDA Approves New Indication for Crestor
-
February 09, 2010 -
FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical
Imaging
- February 08, 2010 -
FDA Updates Statement on the Investigation into the Salmonella Montevideo
Outbreak
- February 05, 2010 -
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
- February 03, 2010 -
United States Seizes more than 1500 Cases of Food from Wisconsin
Distribution Warehouse
- February 02, 2010 -
FDA Approves Xiaflex for Debilitating Hand Condition
- February 01, 2010 -
FDA Requests $4.03 Billion to Transform Food Safety System, Invest in
Medical Product Safety, Regulatory Science
- February 01, 2010 -
FDA Announces Safety Risk Associated with HIV Drug
- February 01, 2010 -
FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for
Children in Developing Countries
- January 29, 2010 -
FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
- January 29, 2010 -
FDA Expands Use of Approved Breast Cancer Drug
- January 29, 2010 -
United States Seizes Unapproved Ozone Generators
- January 26, 2010 -
FDA Announces Class I Recall of Certain Infusion Set Needles
- January 26, 2010 -
FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic
Pain
- January 25, 2010 -
FDA Approves New Treatment for Type 2 Diabetes
- January 25, 2010 -
FDA Approves First Percutaneous Heart Valve
- January 22, 2010 -
FDA Schedules Public Meeting on Premarket Clearance Process for Medical
Devices
- January 22, 2010 -
FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
- January 20, 2010 -
FDA Approves Left Ventricular Assist System for Severe Heart Failure
Patients
- January 19, 2010 -
U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in
Connection with Unlicensed Cosmetic Treatments
- January 18, 2010 -
FDA Warns Consumers about Counterfeit Alli
- January 15, 2010 -
FDA Commissioner Addresses Nation's Health Care Professionals on H1N1
Vaccine Safety
- January 15, 2010 -
U.S. Attorney New Release: Anesthesiologist Charged With Falsifying Medical
Research
- January 14, 2010 -
FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and
Distributed by Merrick Pet Care
- January 14, 2010 -
FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
- January 13, 2010 -
FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 &
Stage 2 Baby Foods
- January 13, 2010 -
U.S. Attorney News Release: Longmont, Colorado Man Arrested For Removing And
Replacing Labels On Gatorade Bottles
- January 12, 2010 -
FDA Unveils First Phase of Transparency Initiative
- January 11, 2010 -
FDA Approves New Drug for Rheumatoid Arthritis
- January 08, 2010 -
FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety
Monitoring System
- January 08, 2010 -
FDA Ends Maryland Seafood Processor’s Pattern of Sanitary Violations
- January 08, 2010 -
FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
- January 06, 2010 -
FDA Seizes More Than $1 Million Worth of Food from Nashville Food Processor
and Warehouse: Agency acts to prevent distribution of food from
rodent-infested facility
- January 04, 2010 -
FDA Takes Action Against New Jersey Cheese Manufacturer
|
|
GXP Academy |
Conferences |
Discussions |
FDA.COM Job Board
|
On-Demand Printing - Custom CRFs
New! -
GLP Master
Handbook -
2009 Canadian GMPs
-
Eudralex Pharmacovigilance Volume 9a
-
Electronic Systems Master
Handbook |
Fax Form |
The e-Newsletter of
What's New with CDER, CDRH & CBER
Distributed by the worlds
leader in Federal Regulations,
GMP Publications, Inc. & FDA.COM
Tel: 866-GXPNews (or 856-810-7331) Fax: 856-810-7339
http://www.gmppublications.com /
http://www.fda.com
John Cuspilich, Sr. Editor, GXPNews
If you would like to advertise in this eNewsletter, call
856-810-1825
|
