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GXPNews.com - FDA News and Announcements - August 11, 2008 - August 15, 2008
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Center for Drug Evaluation &
Research (CDER) News

Center for Biologics Evaluation &
Research (CBER)

Center for Device &
Radiological Health (CDRH)

Federal Register - Meetings, Notices, & Rule Changes

August 15, 2008

Drug Approval Reports
- NDA and BLA Approvals (updated)
- New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
- NME Drug and New Biologic Approvals (updated)
- Priority NDA and BLA Approvals (updated)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

August 14, 2008

Medical Center Pharmacy v. Mukasey

August 13, 2008

CDER Organization Charts [HTML] [PDF] (updated)
Drugs@FDA Downloadable Data Files (updated)
New and Generic Drug Approvals
- Docetaxel Injection, Hospira, Inc., Tentative Approval
- Fluorouracil Injection, Ebewe Pharma, Approval
- Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca LP, Manufacturing Change or Addition
- Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., New or Modified Indication
Watson Pharmaceuticals, Inc. issues a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches. MedWatch Safety Information

August 12, 2008

FDA issues an Information for Healthcare Professionals sheet for Naltrexone. Drug Information.
New and Generic Drug Approvals
- Ak-Fluor (fluorescein sodium) Injection, Akorn, Inc., Approval
- Cefazolin Injection, Aurobindo Pharma, Ltd., Approval
- Zovirax (acyclovir) Capsules, GlaxoSmithKline, Labeling Revision
- Zovirax (acyclovir) Oral Suspension, GlaxoSmithKline, Labeling Revision
- Zovirax (acyclovir) Tablets, GlaxoSmithKline, Labeling Revision

August 11, 2008

Cyber Letters for year 2005 and 2006 (updated)
Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution
New and Generic Drug Approvals
- Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
- Cefepime Injection, Baxter Healthcare Corp., Approval
- Corzide (bendroflumethiazide and nadolol) Tablets, King Pharmaceuticals, Labeling Revision
- Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Kerlone (betaxolol hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
- Ramipril Capsules, Cipla Ltd, Approval
- Talacen (acetaminophen and pentazocine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision

CDER Drug Links

Approval Information: Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone)
Posted: 8/15/2008, Approval Date: 8/14/2008

Approval Information: Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone)
Posted: 8/15/2008, Approval Date: 8/14/2008

Approval Information: Blood Grouping Reagent Anti-Fy^a (Monoclonal) (Seraclone)
Posted: 8/15/2008, Approval Date: 8/14/2008

Supplement Approval: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic) (PROCLEIX ULTRIO Assay) - Gen-Probe Inc
Posted: 8/15/2008, Approval Date: 8/12/2008

Substantially Equivalent 510(k) Device - SoftBank II v23.2 - SCC Soft Computer
Posted: 8/15/2008, Clearance Date: 8/12/2008

Substantially Equivalent 510(k) Device - Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 - LifeSouth Community Blood Centers Inc
Posted: 8/15/2008, Clearance Date: 8/5/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/13/2008

Cleared Biological 510(k) Device Applications - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Approved Biological NDA and ANDA Applications - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Licensed Products and Establishments List - Update
Posted: 8/13/2008, Updated through: 7/31/2008

Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Transcripts
Posted: 8/12/2008

Blood Products Advisory Committee Meeting
Posted: 8/12/2008; Meeting Date: 9/10-11/2008

CBER Foreign Regulators Seminar Agenda
Posted: 8/12/2008; Meeting Date: 10/14-16/2008

Letter: Regenerative Sciences, Inc
Posted: 8/11/2008

Substantially Equivalent 510(k) Device - Donor Screen HLA Class I and Class II - GTI, INC
Posted: 8/11/2008, Clearance Date: 7/30/2008

Substantially Equivalent 510(k) Device - XM-ONE Transplantation Cross Match - AbSorber AB
Posted: 8/11/2008, Clearance Date: 7/29/2008

Substantially Equivalent 510(k) Device - ALBAcheck - BGS Reagent Control for Anti-D -ALBA Bioscience
Posted: 8/11/2008, Clearance Date: 7/29/2008

Vacancy Announcement - Administrative Support Assistant (OA), WOPT/OM
Posted: 8/11/2008

August 15, 2008
	Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff

August 14, 2008
	Class I Medical Device Recall: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System
	FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008
	Federal Register: Medical Devices; Radiology Devices; Reclassification of Bone Sonometers; Correction

August 12, 2008
	Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 15, 2008 - Transcripts

Medical Device Links

Weekly Rule Changes
101 - 892

Friday, August 15, 2008

RULES
Food Labeling:
     Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease,
     47828–47829 [E8–18863]   [TEXT]  [PDF]

NOTICES
Meetings:
     Bisphenol A Subcommittee of the Science Board,
     47957 [E8–18864]   [TEXT]  [PDF]

Thursday, August 14, 2008

RULES
Medical Devices; Radiology Devices; Reclassification of Bone Sonometers; Correction,
47523 [E8–18792] [TEXT] [PDF]

Wed., August 13, 2008

NONE

Tuesday, August 12, 2008

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
46909–46911 [E8–18570] [TEXT] [PDF]

Monday, August 11, 2008

NONE

FDA Handbooks

EU - US - ICH GMP
Combination Product handbook

US GMP Training Booklet

Std. GMPs - Parts 11, 210, 211, 820 & ICH Q7

Med. Device - 11, 50, 54, 56, 807, 812, 814, 820, 510k/PMA

Clinical GCP - Parts 11, 50, 54, 56, 312, 314 & ICH E2A & E6

Multi-US GMPs 11, 58, 210/211, 600, 601, 610 & 820

Parts 210/211 - Drug GMPs

>210/211 with Part 11

>210/211 with Part 820

>210/211 with Parts 820 & 11

>210/211 w/ Keyword Index

Part 820 Quality Systems Regs

Part 58 - GLP Good Lab. Practice

Part 11 - Electronic Records w/ Scope and Applications

GLP 2 11 & 58 - Part 11 & 58

PDMA 11, 203 & 205 - Prescription Drug Marketing

11 & 210/211 w/ Keyword Index

11 & 820 Electronic Record and Quality Systems

Biological GMPs 600, 601, 610

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