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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
May 1, 2009
  • Drugs@FDA Downloadable Data Files (updated)
  • FDA approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information
  • New and Generic Drug Approvals
    • AVELOX (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation Labeling Revision
    • AVELOX (moxifloxacin hydrochloride in NaCl injection) I.V, Bayer Pharmaceuticals Corporation Labeling Revision
    • Cetirizine Hydrochloride Syrup, Dr. Reddy's Laboratories, Inc., Approval
    • CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation, Labeling Revision
    • CIPRO IV (ciprofloxacin) 1% Solution in Vials, Bayer Pharmaceuticals Corporation, Labeling Revision
    • CIPRO IV (ciprofloxacin) 0.2% Solution in 5% Dextrose, Bayer Pharmaceuticals Corporation, Labeling Revision
    • CIPRO (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corporation, Labeling Revision
    • CIPRO XR (ciprofloxacin) Extended-Release Tablets, Bayer Pharmaceuticals Corporation, Labeling Revision
    • Creon (pancrelipase) Delayed-Release Capsules, Solvay Pharmaceuticals, Approval
    • Donepezil Hydrochloride Tablets, Apotex Inc., Tentative Approval
    • Duraclon (clonidine hydrochloride) Injection, Xanodyne Pharmaceuticals, Inc., Labeling Revision
    • Equetro (carbamazepine) Extended-Release Capsules, Validus Pharmaceuticals, Labeling Revision
    • Ezetimibe Tablets, Glenmark Generics Limited, Tentative Approval
    • Felbatol (felbamate) Tablets and Oral Suspension, Meda Pharmaceuticals Inc., Labeling Revision
    • Fexofenadine Hydrochloride Tablets, Sandoz Inc., Tentative Approval
    • Gabitril (tiagabine hydrochloride) Tablets, Cephalon, Inc., Labeling Revision
    • GLYCET (miglitol) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
    • Kayexalate (sodium polystyrene sulfonate) Powder, Sanofi-Aventis U.S. LLC, Labeling Revision
    • Keppra (levetiracetam) Tablets, UCB, Inc., Labeling Revision
    • Keppra (levetiracetam) Oral Solution, UCB, Inc., Labeling Revision
    • Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Labeling Revision
    • Levofloxacin Ophthalmic Solution, Apotex Inc., Tentative Approval
    • Linezolid Tablets, Glenmark Generics Limited, Tentative Approval
    • Motrin IB (ibuprofen) Tablets, McNeil Consumer Healthcare, Labeling Revision
    • Motrin Junior Strength (100 mg ibuprofen) Tablets, McNeil Consumer Healthcare, Labeling Revision
    • Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Labeling Revision
    • Stavzor (valproic acid) Delayed Release Capsules, Banner Pharmacaps Inc., Labeling Revision
    • Tarceva (erlotinib) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision
    • Topamax (topiramate) Tablets, Johnson & Johnson Pharmaceutical, Labeling Revision
    • Topamax (topiramate) Sprinkle Capsules, Johnson & Johnson Pharmaceutical, Labeling Revision
    • Velcade (bortezomib) Injection, Millennium Pharmaceuticals, Inc., Manufacturing Change or Addition
    • Zonegran (zonisamide) Capsules, Dainippon Pharmaceutical USA Corporation, Labeling Revision
  • Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

April 30, 2009

April 29, 2009

April 28, 2009

  • Manual of Policies and Procedures (MaPP) 5100.4 Scientific Interest Groups: Criteria and Policies
  • Drug Shortages: Current Drug Shortage: Morphine Sulfate Oral Solution (updated)
  • New and Generic Drug Approvals
    • BSS (calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride and sodium citrate) Irrigation Solution, Alcon Laboratories, Inc., Package Change
    • Carbatrol (carbamazepine) Extended-Release Capsules, Shire Development, Inc., Labeling Revision
    • Celontin (methsuximide) Capsules, Pfizer, Inc., Labeling Revision
    • Dilantin-125 (phenytoin) Oral Suspension, Pfizer, Inc., Labeling Revision
    • Neurontin (gabapentin) Capsules, Pfizer, Inc., Labeling Revision
    • Neurontin (gabapentin) Tablets, Pfizer, Inc., Labeling Revision
    • Neurontin (gabapentin) Oral Solution, Pfizer, Inc., Labeling Revision
    • Peganone (ethotoin) Tablets, Ovation Pharmaceuticals, Inc., Labeling Revision
    • Pristiq (desvenlafaxine succinate) Extended-Release Tablets, Wyeth Pharmaceuticals Inc., Control Supplement
    • Tranxene (clorazepate dipotassium) Capsules, Ovation Pharmaceuticals, Inc., Labeling Revision
    • Zarontin (ethosuximide) Capsules, Pfizer, Inc., Labeling Revision
  • The U.S. Food and Drug Administration and the U.S. Substance Abuse and Mental Health Services Administration launched an initiative to help ensure the safe use of methadone. For more information on the campaign, or to download free copies of the educational materials, please visit www.dpt.samhsa.gov/
    methadonesafety

April 27, 2009

CDER Drug Links

Hot Topics

H1N1 Virus (Flu) Information

GARDASIL (Human Papillomavirus Vaccine)

Zostavax (Herpes Zoster Vaccine)

Advisory Committees

Blood Establishment Registration

FDA's Office of Criminal Investigations (OCI)

Forms

Guidances/Guidelines/Points to Consider

Impact of Severe Weather Conditions on Biological Products

Proposed and Final Rules

Human Cell and Tissue Establishment Registration

Recall & Product Withdrawals

Reporting Adverse Events and Product Deviations

Safety Information

Shortages

What's New

CBER Links

 

 
May 1, 2009
* PMA Final Decisions for March 2009 Text
 
April 30, 2009
* Neurological Devices Panel Advisory Meeting, May 14, 2009 - Waivers for Conflicts of Interest Text
 
April 29, 2009
* Ophthalmic Devices Panel Advisory Meeting, March 27, 2009 - Transcript Text
* Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, March 31, 2009 - Transcript Text
 
April 28, 2009
* Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting TextPDF
* Letter of Authorization: Emergency Use of the Swine Influenza Virus Real-time RT-PCR Detection Panel TextPDF
* Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting TextPDF
* Report to Congress: Premarket Approval of Pediatric Uses of Devices - FY 2008 TextPDF
 
April 27, 2009
* Circulatory System Devices Panel Advisory Meeting, April 23, 2009 - Agenda, Roster, Briefing, Questions, Brief Summary Text
* Federal Register: Computational Modeling for Cardiovascular Devices; Public Workshop TextPDF
 
 
News & Events
FDA Public Health Advisory - Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings
FDA Press Release: FDA Warns About Risk of Wearing Medicated Patches During MRIs
National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Thinktank (April 27-28, 2009)
FDA Unique Device Identification Public Workshop: February 12, 2009
Public Health Notifications:
• Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
• Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status
Class I Medical Device Recalls -
• Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED
• Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps
• Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube
• Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
• Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades

FDA Patient Safety News - A Video News Show for Health Professionals

Medical Device Links

 

This Week Rule Changes:
 21 CFR Part 526 - 201 - 524
 CFR Changes since April 2008

Friday, May 01, 2009
NOTICES
 Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability
 20322–20323 [E9–10005]   [TEXT]  [PDF]

 Guidance for Industry:
     Small Entities Compliance Guide for Renderers Substances, etc; Availability
     20324–20325 [E9–10034]   [TEXT]  [PDF]
 

Thursday, April 30, 2009
RULES
 Ophthalmic and Topical Dosage Form New Animal Drugs:
     Selamectin
     19877–19878 [E9–9901]   [TEXT]  [PDF]

NOTICES
 Small Entity Compliance Guide:
     Bottled Water: Arsenic; Availability
     19972–19973 [E9–9870]   [TEXT]  [PDF]
     Bottled Water: Uranium; Availability
     19972 [E9–9867]   [TEXT]  [PDF]
     Cochineal Extract and Carmine; Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives; Availability
     19973 [E9–9868]   [TEXT]  [PDF]
 

Wednesday. April 29, 2009
RULES
 Final Monograph:
     Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
     19385–19409 [E9–9684]   [TEXT]  [PDF]
 

Tuesday, April 28, 2009
NOTICES
 Agency Information Collection Activities; Proposals, Submissions, and Approvals
 19225–19226 [E9–9632]   [TEXT]  [PDF]

 Meetings:
     Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
     19230–19231 [E9–9642]   [TEXT]  [PDF]
     Cellular, Tissue and Gene Therapies Advisory Committee
     19226–19227 [E9–9592]   [TEXT]  [PDF]
     Neurological Devices Panel of the Medical Devices Advisory Committee
     19231–19232 [E9–9641]   [TEXT]  [PDF]
     Science Board to the Food and Drug Administration
     19231 [E9–9643]   [TEXT]  [PDF]
 

Monday, April 27 2009

RULES
 Intramammary Dosage Forms:
     Change of Sponsor,
     18990 [E9–9527]   [TEXT]  [PDF]

NOTICES
 Draft Guidance for Industry and Food and Drug Administration Staff:
     Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products; Availability
     19094–19095 [E9–9519]   [TEXT]  [PDF]

 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products:
     Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43; Availability
     19096–19097 [E9–9521]   [TEXT]  [PDF]

 Meetings:
     Computational Modeling for Cardiovascular Devices; Public Workshop
     19097–19098 [E9–9474]   [TEXT]  [PDF]
 

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