• Podcast Transcript - FDA's Action Against Marketing Unapproved Drugs
• International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

October 16, 2008

• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files
• Drug Master Files (updated)
• Ethex Corp and FDA notify healthcare professionals of a voluntary recall of three lots of dextroamphetamine sulfate 5mg tablets. MedWatch Safety Information
• FDA creates a consolidated web page with drug safety information for patients and health care professionals. FDA News
• Paragraph IV Patent Certifications (updated)
• Prescription Drug User Fee Act (PDUFA) Billable Products (updated)

October 15, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New pages for Rheumatology Therapeutics.

October 14, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• New and Generic Drug Approvals
  • AmBisome (amphotericin B) Liposome Injection, Astellas Pharma US, Inc., Labeling Revision
  • Cetirizine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval
  • Dantrium (dantrolene sodium) Injection, JHP Pharmaceuticals, Labeling Revision
  • Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Packaging Addition
  • Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Packaging Addition
  • Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Packaging Addition
  • Letairis (ambrisentan) Tablets, Gilead Sciences, Inc., Labeling Revision
  • Prinivil (lisinopril) Tablets, Merck Research Laboratories, Labeling Revision
  • Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Research Laboratories, Labeling Revision
  • Prismasol Solutions Gambro Lundia AB, Formulation Revision
  • Rapflo (silodosin) Capsules, Watson Laboratories, Inc., Approval
  • Risperdal Consta (risperidone) Intramuscular Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
  • Risperidone Tablets, Aurobindo Pharma Ltd., Approval
  • Risperidone Tablets, Wockhardt Ltd., Approval
  • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication
  • Vaprisol (conivaptan hydrochloride) I.V. Injection, Astellas Pharma US, Inc., Formulation 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

Hot Topics

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

October 15, 2008 Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Summary Information for: TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) - In-Stent Restenosis (ISR) Indication   October 14, 2008 Information on Cell Phones (Updated)     News & Events • Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product • Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Public Health Notifications: • Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status • Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning Class I Medical Device Recalls - • Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) • Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank • Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System   FDA Patient

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