New!  -  US & Chinese 820 Combination Pocket Size Handbooks - Canadian GMP - Device - Clinical - Call 856-810-7331
Medical Device QSIT Handbook  -  Medical Device Quality Manuals  -  EU / US Handbooks  -  GMP Training Courses

Center for Drug Evaluation &
Research (CDER) News

• AAPS Workshop; Utilization of Process Modeling & Advanced Process Control in QbD Based Drug Development and Manufacturing, April 27-28, 2009, Sheraton Inner Harbor Hotel, Baltimore, MD. Meeting Information
• FDA Data Standards Manual: Drug Nomenclature Monograph (updated)
• New and Generic Drug Approvals
  • Alfuzosin Hydrochloride Extended-Release Tablets, TEVA Pharmaceuticals USA, Tentative Approval
  • Tri-Nasal (triamcinolone acetonide) Nasal Spray, Collegium Pharmaceutical, Control Supplement
  • Ciclopirox Gel, Paddock Laboratories, Inc., Approval
  • Genotropin (somatropin recombinant) Injection, Pharmacia & Upjohn Co., Control Supplement
  • Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Labeling Revision
  • Stavudine Capsules, Matrix Laboratories, Ltd., Approval
  • Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

January 8, 2009

• Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products (updated)
• Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). Information
• Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
  • Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter [PDF] or [HTML] 
  • Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter [PDF] or [HTML]

January 7, 2009

• Drugs@FDA Downloadable Data Files (updated)
• Investigational Human Drugs: Clinical Investigator Inspection List (updated)
• New and Generic Drug Approvals
  • ActoPlus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Celebrex (celecoxib) Capsules, Pfizer Inc., New Dosage Regimen
  • Duetact (pioglitazone hydrochloride and glimepiride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Eldepryl (selegiline hydrochloride) Tablets, Somerset Pharmaceuticals, Inc., Labeling Revision
  • Etomidate Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval
  • Protopic (tacrolimus) Ointment, Astellas Pharma US, Inc., Manufacturing Change or Addition
  • Requip (ropinirole hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Sinemet (carbidopa and levodopa) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Sinemet CR (carbidopa and levodopa) Extended-ReleaseTablets, Bristol-Myers Squibb Co., Labeling Revision
  • Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Inc., Labeling Revision

January 6, 2009

• Division of Drug Marketing, Advertising, and Communications - Research (updated)
• New and Generic Drug Approvals
  • Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma Ltd., Tentative Approval
  • Coreg (carvedilol) Tablets, GlaxoSmithKline, Labeling Revision
  • Coreg CR (carvedilol phosphate) Extended-Release Capsules, GlaxoSmithKline, Approval
  • Casodex (bicalutamide) Tablets, AstraZeneca Pharmaceuticals LP, Approval
  • Dianeal Pd-1 w/ Dextrose 2.5% in Plastic Container (calcium chloride, dextrose, magnesium chloride, sodium chloride and sodium lactate) Intraperitoneal Solution, Baxter Healthcare Corp., Labeling Revision
  • Geodon (ziprasidone meyslate) Intramuscular Injection, Pfizer, Inc., Manufacturing Change or Addition
  • Lotrisone (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision
  • Mirapex (pramipexole dihydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Prezista (darunavir ethanolate) Tablets, Tibotec, Inc., Patient Population Altered
  • Reclast (zoledronic acid) I.V. Injection, Novartis Pharmaceuticals Corp., New or Modified Indication
  • Sensipar (cinacalcet hydrochloride) Tablets, Amgen Inc., Labeling Revision
  • Xolegel (ketoconazole) Gel, Barrier Therapeutics, Inc., Package Change
  • Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets, Valeant Pharmaceuticals International, Labeling Revision
  • Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision
  • Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, New Dosage Regimen
  • Zolpimist (zolpidem tartrate) Inhalation Spray, NovaDel Pharma, Inc., Approval

January 5, 2009

• On Dec. 31, 2008, Celgene issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. MedWatch Safety Alert
• Guidance for Industry:
  • Comprehensive List of Guidance Documents
  • New/Revised/Withdrawn List for 2008
• Paragraph IV Patent Certifications (updated)

CDER Drug Links

• Guidance

• Approved Drugs

• Approval Process

• Electronic Submissions

• Firm Registration Status

• Postmarketing Study Commitments

• Good Manufacturing Practice Regulations

• National Drug Code Directory

• MedWatch: Adverse Event Reporting

• Forms

• Presentations

• Meetings/Workshops

• Generic Drugs

• Pharmacology//Toxicology

• Small Business

• En Español

• Contact the Center for Drug Evaluation and Research

• CDER Presentations

• CDER Meetings

January 6, 2009
	Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, December 5, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary, Slides
	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability.
	Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide
January 5, 2009
	510(k) Final Decisions - December 2008

Medical Device Links

• Guidance

• Industry Assistance

• Software Validation

• Design Control Guidance

• Good Manufacturing Practice/Quality Systems

• In Vitro Diagnostic Device Evaluation and Safety

• Device Advice

• Device Listing

• Establishment Registration

• Workshops and Conferences

• Advisory Meetings

• Medical Device Reporting

• Medical Device Databases

• Forms

• Contact the Center for Devices and Radiological Health

• CDRH Workshops

• CDRH Advisory Committees/Panel Meetings

• Combination Products

• Device Advice

• Electronic Submissions / eCopies

• Guidance documents

• Importing in the U.S.

• Industry Support

• International issues

• Medical device reporting (MDR)

• Getting market clearance / approval

• Ombudsman

• Standards

• STED Pilot Program

• Third party review

• Third party inspection