• New and Generic Drug Approvals
  • ARESTIN (minocycline hydrochloride) Microspheres, OraPharma Inc., Labeling Revision
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision
  • Avelox (moxifloxacin hydrochloride in NaCl) I.V., Bayer Pharma, Labeling Revision
  • Irinotecan Hydrochloride Injection, Watson Labs, Approval
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Pramipexole Dihydrochloride Tablets, Barr Labs, Approval
  • Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb, Labeling Revision
  • Ultram ER Extended-Release Tablets, Biovail Labs, Labeling Revision

February 20, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Drug Shortages
  • Current Shortage: Baxter 1000u/mL heparin vials in 10mL and 30mL sizes
  • Drug to be Discontinued: Zyflo (zileuton) tablets
• Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF] or [HTML]
  • Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF] or [HTML]
• Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)

February 19, 2008

• CDER Key Officials
• New and Generic Drug Approvals
  • Cefuroxime Axetil Tablets, Orchid Healthcare, Approval
  • Cetirizine Hydrochloride Chewable Tablets, Sandoz Inc., Approval
  • Lamotrigine Tablets, Sandoz Inc., Tentative Approval
  • Metoprolol Succinate Extended Release Tablets, AstraZeneca, Control Supp.
  • Nadolol and Bendroflumethiazide Tablets, Mylan Pharma, Approval
  • SIMCOR (niacin extended-release/simvastatin) Tablets, Abbott Labs, Approval
  • Tekturna (aliskiren) Tablets, Novartis Pharma, Labeling Revision

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

CBER Links

• Allergenics

• Blood

• Cellular & Gene Therapy

• Devices

• Tissues

• Vaccines

• Xenotransplantation

• Consumer & Healthcare Information

• eFOIA Reading Room

• Industry

• Meetings

• Product Information

• Scientific Expertise & Research

• Guidance

• Letters to Industry

• Manufacturers Assistance

• Approvals

• Labeling

• IND Process

• Adverse Experience Reporting

• Product Deviation Reporting

• Meetings/Workshops

• Forms

• Contact the Center for Biologics Evaluation and Research

• CBER Meetings

February 22, 2008 Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products   February 20, 2008 Federal Register: Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability. PMA Final Decisions for January 2008   February 19, 2008 Medical Device Safety Article: Epidural Conduction Device Fractures and Complications of Retained Fragments Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Nature and Basis Statements of Conflict(s) of Interest Risk Communication Advisory Committee; Notice of Meeting

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