If you are having problems viewing this page, load here

GXPNews.com - FDA News and Announcements - December 14 - December 18, 2009

The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)

FDA Handbooks - Drug GMP Handbooks  |  Clinical Handbooks  |  Device Handbooks  |  Biological Handbooks

GMP Publications 2010 FDA Regulation Handbooks

 FDA.COM Food and Drug Assistance for Industry and Consumers

Distributed by the leader in Federal Regulations, GMP Publications, GXPNews & FDA.COM - RA/QA Editor
Books>Pharma GMPsMedical DeviceClinicalFood-Diet-CosmeticBiologic-Cell-BloodLaboratoryPart 11EU-Can-Misc.

New! - GLP Master Handbook - Clinical Master Reference Guide - 2009 Canadian GMPs - Pharmacovigilance Vol. 9a -  Electronic Systems Handbook

Get a free copy of the 650 page Clinical Master Reference Guide - Click for details

Stay up to date with the Code of Federal Regulations changes - Enter Email:     Archive

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
CDER News
Drug Approvals
December 18, 2009

December 17, 2009

  • Daytrana (methylphenidate) Patch,Shire Development, Inc., Labeling Revision
  • Verelan PM (verapamil hydrochloride) Extended-Release Capsules, Elan Drug Delivery, Inc., Labeling Revision

December 16, 2009

  • Arranon (nelarabine) I.V. Injection, GlaxoSmithKline, Labeling Revision
  • Stromectol (ivermectin) Tablets, Merck and Co., Inc., Labeling Revision

December 15, 2009
CDER Meetings
  • 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
  • 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration.
CDER Links

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

CBER News
CBER Meetings - NONE

 
CBER 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.

CDRH News

December 18, 2009

December 17, 2009

December 11, 2009
CDRH Meetings
Public Meeting: Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health - February 9, 2010
 
CDRH Links
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 

This Week CFR Rule Changes
Thursday - 558
Wednesday - 510 - 522
Monday - 510 - 522
Fri, December 18, 2009
RULES - NONE

 
NOTICES
Meetings:
     Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health
     67237–67238 [E9–30114]   [TEXT]  [PDF]
 
Thurs, December 17, 2009
RULES
New Animal Drugs for Use in Animal Feeds:
     Ractopamine; Tylosin
     66914–66915 [E9–29998]   [TEXT]  [PDF]
 
NOTICES
Filing of Food Additive Petition:
     Lallemand, Inc.
     66979 [E9–29961]   [TEXT]  [PDF]

International Conference on Harmonisation:
     Draft Guidance on Addendum to S6; Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)
     66980–66981 [E9–29991]   [TEXT]  [PDF]
     Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts, etc.; Annex 11 on Capillary Electrophoresis General Chapter
     66981–66982 [E9–29990]   [TEXT]  [PDF]
     Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts, etc.; Annex 12 on Analytical Sieving General Chapter
     66982–66983 [E9–29988]   [TEXT]  [PDF]

Meetings:
     Oncologic Drugs Advisory Committee
     66986–66987 [E9–29989]   [TEXT]  [PDF]

Public Workshops:
     Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practices
     66988–66989 [E9–30017]   [TEXT]  [PDF]
 
Wed, December 16, 2009
RULES
Implantation or Injectable Dosage Form New Animal Drugs:
     Florfenicol
     66573–66574 [E9–29875]   [TEXT]  [PDF]
New Animal Drugs:
     Change of Sponsor; Ketamine
     66573 [E9–29888]   [TEXT]  [PDF]
 
NOTICES


 
Tue, December 15, 2009
RULES - NONE

 
NOTICES - NONE

 
Mon, December 14, 2009
RULES
Implantation or Injectable Dosage Form New Animal Drugs:
     Insulin
     66047–66048 [E9–29583]   [TEXT]  [PDF]
New Animal Drugs; Change of Sponsor's Name and Address
66047 [E9–29627]   [TEXT]  [PDF]
 
NOTICES
Debarment Order:
     Peter Xuong Lam
     66133–66134 [E9–29715]   [TEXT]  [PDF]
 
 
 

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