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What's New by Category

This page lists new and revised documents posted to the CDER web site. Each listing will remain on this page approximately 30 days. The dates listed indicate the dates of posting to the CDER web site, not the dates of origination or revision. When viewing a document, click your browser's "refresh" or "reload" button to make sure you are seeing the latest version.

In the News

FDA and Abbott Pharmaceuticals notify healthcare professionals of revisions to the WARNINGS section of the prescribing information for Humira (adalimumab), indicated for the treatment of rheumatoid arthritis. MedWatch Safety Info. (11/8/2004)
The FDA has written a proposed Medication Guide about Using Antidepressants in Children or Teenagers and sent this Medication Guide to all the sponsors on October 21, 2004. (11/4/2004)
FDA announces a draft guidance to change the generic drug approval process. Draft Guidance. (11/4/2004)
FDA announces important labeling changes for Mifeprex (mifepristone, also known as RU-486). Mifeprex Information. (11/15/2004)
FDA announces measures to bolster drug safety evaluations. FDA Statement. Documenting Differing Professional Opinions and Dispute Resolution Pilot Program. (11/5/2004)
FDA approves first-time generic Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for the treatment of small uncomplicated varicose veins of the lower extremities. The reference listed drug is Sotradecol Injection. (11/12/2004)
FDA today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior ("suicidality") in children and adolescents being treated with antidepressant medications. (10/15/2004) More Information

CDER Organization Charts
- Center for Drug Evaluation Research Organizational Chart (Updated 11/2/2004)
- Office of Center Director (Updated 11/2/2004)
- Office of Management (Updated 11/2/2004)
- Office of Pharmaceutical Sciences (Updated 11/2/2004)
- Office of Pharmacoepidemiology and Statistical Science (Updated 11/2/2004)
- Office of New Drugs (Updated 11/2/2004)
CDER Key Officials (11/10/2004)
Manual of Policies and Procedures (MaPP) 4601.3 Children in the Workplace (10/18/2004)
New Drug Approval Reports
- FY 2004 Priority Approvals (11/10/2004)
- FY 2004 User Fee NME Drug and New Biologic Approvals (11/10/2004)
- NDA Approval Rates for Standard NDAs Received FY 93-03 and Approved within 36 Months (11/10/2004)
- NDA Approval Rates for Priority NDAs Received FY 93-03 and Approved within 36 Months (11/10/2004)
News Along the Pike; August 2004 [HTML] or [PDF]
Office of Generic Drugs
- Approvals (11/2/2004)
- First-Time Generics (11/2/2004)
- Tentative Approvals (11/2/2004)
- Paragraph IV Patent Certifications (11/2/2004)
- Suitability Petition Reports (9/8/2004)

Consumer Drug Information Sheets
- Sanctura (8/17/2004)
Drug Approval Reports
- FY 2004 Priority Approvals (updated 11/2/2004)
- FY 2004 User Fee NME Drug and New Biologic Approvals (updated 11/2/2004)
Drug Shortage: Re solved; Amphadase (hyaluronidase) injection, USP, 150 IU mL (10/29/2004)
Drug Shortage: Current; Folic Acid injection (11/9/2004)
National Drug Code (NDC) Directory (10/7/2004)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter] (Updated)
Orange Book: Query (9/28/2004)
Orange Book: Cumulative Supplement No 8 (9/28/2004)
Orange Book: Information and Data Files (9/28/2004)
Orange Book: Monthly Additions and Deletions (9/28/2004)
Vioxx: 9/30/2004 Study Report (11/2/2004)

Bioresearch Monitoring Information System File (10/4/2004)
Manual of Policies and Procedures (MaPP) (updated)
- 4115.1 Public Dissemination of a Summary of the Medical and Clinical
  Pharmacology Reviews of Pediatric Studies
- 7400.4 Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies
- 7400.5 Management of the PTCC Education Subcommittee
National Drug Code (NDC) Directory (updated 7/13/2004)
Patent Term Extension and New Patents Docket Number *95S-0117. This file lists new (7/1/2004) and cumulative (2/6/2004) drug patent and exclusivity information.
Postmarketing Study Commitments Database (updated 7/30/2004)

Prescription Drug User Fee Act (updated)

The FY 2004 "cleanup" invoices were mailed out November 15, 2004. The payments are due to FDA by December 15, 2004. If you didn't get an invoice, and you have a new product or establishment approved during FY 2004, please contact the user fee staff.

The phone number to obtain a UFID number for CDER applications and supplements has been changed. Please call 301-210-2880 for assignment of a UFID number. (11/15/2004)

Cyber Warning Letters for June and September, 2004 (10/13/2004)
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
- Kaletra (lopinavir/ritonavir) Capsules and Oral Suspension (11/2/2004)

Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 -- Questions and Answers [HTML] or [Word] or [PDF]. (Issued 10/2004, Posted 11/3/2004)
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [PDF] or [Word] (9/10/2004)
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [PDF] or [Word] (9/10/2004)
Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application [Word] or [PDF] (8/13/2004)
Guidance Document: Independent Consultants for Biotechnology Clinical Trial Protocols - [HTML] or [PDF] (8/19/2004)
Guidance Document: The Use of Clinical Holds Following Clinical Investigator Misconduct [PDF] or [Word] (9/3/2004)

Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Products. Federal Register notice [HTML] or [TXT] or [PDF] (9/29/2004)

Pharmaceutical Good Manufacturing Practices Guidances 9/29/2004)

Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations [HTML] or [PDF]

Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance [HTML] or [PDF]

Guidance for Industry: and FDA — Current Good Manufacturing Practice for Combination Products [HTML] or [PDF]

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [HTML] or [PDF]

Draft Guidance for Industry Computerized Systems Used in Clinical Trials [HTML] or [PDF]

FDA/ISPE Forum on New PAT Guidance, November 16, 2004, Arlington, VA (international locations also available) Meeting Information (10/18/2004)
Public Meeting - Radioactive Drugs for Certain Research Uses. November 16, 2004, Rockville, MD. Meeting Information (10/5/2004)
Public Workshop: Scientific Considerations Related to Developing Follow-On Protein Products, September 14-15, 2004. Federal Register Notice: [TXT] [PDF] Agenda (9/10/2004)
Tentative Advisory Committee Meetings, CDER (updated 7/7/2004)

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FDA/Center for Drug Evaluation and Research

Presentation: Biopharmaceutics and Drug Product Quality: Performance Tests for Drug Products, A Look Into the Future, Ajaz S. Hussain, Ph.D. CDER, USP Annual Scientific Meeting, September, 2004. [PDF] (10/6/2004)
BPCA/Pediatric Exclusivity Statistics
- Pediatric Exclusivity Granted (9/30/2004)
- Pediatric Exclusivity Labeling Changes (11/15/2004)
- Breakdown of Requested Studies Report (11/10/2004)
- Written Requests Issued (11/10/2004)
- Pediatric Exclusivity Statistics (11/10/2004)
- Spectrum of Diseases/Conditions (11/10/2004)
BPCA/Off-Patent Drugs
- Approved Active Moieties for which FDA has Issued a Written Request for Pediatric Studies under Section 3 of the Best Pharmaceuticals for Children Act (9/30/2004)
National Recruitment Efforts Underway for Director of Oncology Drug Products in CDER’s Office of New Drugs (10/6/2004)
Online Tutorial - Field Investigators: Adverse Drug Effects (ADE) Investigators (2000) (10/28/2004)

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Date revised: November 15, 2004