Recent FDA Links
 

• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 5/9/2008)
   
• Office of Generic Drugs: April First-Time Generic Drug Approvals (5/9/2008)

May 8, 2008

1. User Fee Billable Products Approved Under Section 351 of the PHS Act - Updated (Posted: 5/8/2008)
    
2. Paragraph IV Patent Certifications (updated 5/8/2008)

May 7, 2008

1. Drugs@FDA Downloadable Data Files (updated 5/7/2008)

1. CDER Manual of Policies and Procedures (MaPPs) 4520.2R Providing General Consumer Information on New Molecular Entities on CDER’s Web Site (5/6/2008)
    
2. DA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07), June 4-5, Washington, DC. Meeting information and registration (5/6/2008)
    
3. Pubic Workshop: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7, 2008, Silver Spring, MD. Federal Register Notice (5/6/2008)

1. Pediatric Research Equity Act of 2007 (PREA) (Posted: 5/5/2008)
    
2. 51st Annual FDLI & FDA Conference - 3/26-27/2008 (Posted: 5/5/2008)
   1. Vaccine Safety Team (PDF - 300 KB) - Carmen M. Collazo, PhD
   2. Safety Surveillance for Licensed Biological Products at FDA's Center for Biologics Evaluation & Research (PDF - 206 KB) - Robert P. Wise, MD, MPH
   3. CBER Safety Initiatives: Tissue Safety Team (PDF - 47 KB) - Ruth Solomon, MD
   4. Blood Safety Team (PDF - 26 KB) - Jonathan C. Goldsmith, MD

1. Drug Safety Oversight Board Roster (updated 5/2/2008)
    
2. Drug Safety Oversight Board Meeting, March 20, 2008 Public Summary (5/2/2008)
    
3. The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information (5/2/2008)

1. Withdrawal of Albumin (Human) 5%, Talecris Biotherapeutics (Posted: 5/1/2008; Withdrawal Date: 4/30/2008)
    
2. Workshop: HL7 SPL Working Group Electronic Drug Registration and Listing Meeting - Webinar (Posted: 4/30/2008, Meeting Date: 5/15/2008)
    
3. Guidance for Industry: Comprehensive List of Guidance Documents (updated 5/1/2008)
    
4. Guidance for Industry: New/Revised/Withdrawn List for 2008 (updated 5/1/2008)
    
5. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 5/1/2008)

1. Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (updated 4/30/2008)
    
2. Drugs@FDA Downloadable Data Files (updated 4/30/2008)
    
3. Postmarketing Study Commitments (updated 4/30/2008)
    
4. Merck Warning Letter- Questions and Answers (Posted: 4/30/2008)
    
5. FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over (4/30/2008)

1. FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule (4/29/2008)
    
2. Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP), a drug used to treat heart failure and abnormal heart rhythms (4/29/2008)
    
3. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 4/29/2008)

1. Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update (Posted: 4/28/2008, Updated as of: 4/28/2008)

1. FDA updates information to healthcare facilities and healthcare professionals about heparin and heparin-containing medical products (4/25/2008)
    
2. Postmarketing Study Commitments: Introduction (updated 4/25/2008)
    
3. FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation (4/25/2008)

April 24, 2008

1. Office of Nonprescription Products: Rx to OTC Switch (updated 4/24/2008)

1. Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Agenda (Posted: 4/23/2008)

1. FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease (4/22/2008)
    
2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 4/22/2008)

1. Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 (Posted 4/21/2008)
    
2. Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc (Posted: 4/21/2008, Notification Date: 4/21/2008)

1. Office of Generic Drugs: March First-Time Generic Drug Approvals (4/18/1008)

1. Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product (Posted 4/17/2008)
    
2. Postmarketing Study Commitments: Introduction (updated 4/17/2008)

1. Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests (PDF - 87 KB) (Posted 4/16/2008)
    
2. CDER issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg" ( 4/16/2008)
    
3. Drugs@FDA Downloadable Data Files (updated 4/16/2008)

1. Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) - Alphabetical List of Registered Establishments - Update (Posted: 4/15/2008)
    
2. Paragraph IV Patent Certifications (updated 4/15/2008)

April 14, 2008

1. Investigational Human Drugs: Clinical Investigator Inspection List (CLIIL) (updated 4/14/2008)

• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated 4/11/08)
   
• Creating New Knowledge: FDA & Industry in Dialogue, May 6, 2008, Philadelphia, PA.  The seventh conference between the FDA and industry sponsored by Temple University School of Pharmacy.  Keynote Speaker: Janet Woodcock, M.D., Director, CDER.  This conference provides participants, industry, and the FDA a forum for dialogue about critical issues affecting drug development. Agenda and registration (4/11/08)

1. Bioresearch Monitoring Information System (BMIS) (updated 4/10/2008)
    
2. Cyber Letters (updated 4/10/2008)
    
3. FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic (4/10/2008)
    
4. New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated 4/10/2008)
    
5. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 4/10/2008)
    
6. Pfizer informs healthcare professionals and patients of updated safety information in the labeling for Exubera, a short-acting insulin (4/10/2008)
    
7. Schwarz Pharma recalls Neupro, a transdermal delivery system used to treat early stage Parkinson’s disease, at the end of April (4/10/2008)
    
8. Recall of Thymoglobulin - Genzyme Corporation (Posted: 4/10/2008, Recall Date: 4/9/2008)
    

1. Fast Track Designation Request Performance Report - Update (Posted: 4/9/2008)
    
2. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (PDF - 251 KB) (4/9/2008)
    
3. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (PDF - 237 KB) (4/9/2008)
    
4. Fast Track Designation Request Performance Report - Update (Posted: 4/9/2008)
    
5. Cubist Pharmaceuticals, Inc. informs healthcare professionals that a potentially significant impurity has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MedWatch Safety Information (4/9/2008)
    
6. Dissolution Methods Database (updated 4/9/2008)
    
7. Drugs@FDA Downloadable Data Files (updated 4/9/2008)
    
8. Research in the Division of Drug Marketing, Advertising, and Communications (DDMAC) (4/9/2008)
    
9. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 4/9/2008)

1. International Conference on Harmonisation (ICH); Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (4/8/2008)
    
2. FDA release information on adverse events and heparin (4/8/2008)
    
3. Impurity Evaluation of Heparin Sodium by ¹H-NMR Spectroscopy (updated 4/8/2008)
    
4. Guidance for Industry: Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document [PDF] (updated 4/8/2008)
    
5. Manuals of Policies and Procedures (MaPPs) (updated 4/8/2008)
   1. 4631.3R Budget Execution Planning and Reporting/Program Management System Reports
   2. 4641.5 Authority to Reimburse Employees for Business Calls Made on Personal Car Phones
   3. 7700.1 Management of the Regulatory Science and Review Enhancement Committee
       
6. Drug Shortages (updated 4/8/2008)
   1. Current Drug Shortage: Neupro (rotigotine transdermal system)
   2. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg

1. FEDERAL REGISTER: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal (4/4/2008)
    
2. National Drug Code Directory Download (updated 4/4/2008)
    
3. National Drug Code Directory Search (updated 4/4/2008)
    
4. Overview of the Regulation of Biological Products (Blood Components and Tissues) - 3/12/2008 (Posted 4/4/2008)
   1. Surveillance and Enforcement (PDF - 88 KB) - Armando Zamora
   2. The Regulation of Biological Products (PDF - 788 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
   3. Regulation of Biological Products - Review (PDF - 711 KB) - Judy Ciaraldi, Linda S. Mattingly, Armando Zamora, Sharon O'Callaghan, Laura St. Martin, MD
   4. FDA Field Inspections (PDF - 60 KB) - Linda S. Mattingly
   5. FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (PDF - 173 KB) - Laura M. St. Martin, M.D., M.P.H.
       
5. CDER Key Officials (Updated 4/4/2008)

1. GlaxoSmithKline informs healthcare professionals of changes to the prescribing information for Relenza regarding information from postmarketing reports. MedWatch Safety Information (4/2/2008)
    
2. Resolved Drug Shortage: BiCNU (updated 4/2/2008)
    
3. Drugs@FDA Downloadable Data Files (updated 4/2/2008)
    
4. CDER Data Standards Manual: SPL Flavor (4/2/2008)
    
5. Meeting: A Joint FDA/URI College of Pharmacy Conference – FDA and Generic Drugs: An Interactive Forum, June 30 and July 1, 2008 / Hyatt Regency Bethesda Hotel ~ North Bethesda, MD. Meeting Information [PDF, External Site] (4/2/2008)
    
6. Novartis will no longer make Zelnorm available under a treatment IND protocol (4/2/2008)

1. FDA/NIST Sponsored Workshop: In Vitro Analyses of Cell/Scaffold Products - Slide Presentations (Posted: 4/1/2008)
    
2. International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information (4/1/2008)
    
3. Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft) (PDF, 4/1/2008)

1. Guidance for Industry: Comprehensive List of Guidance Documents and New/Revised/Withdrawn List for 2008 (Updated 3/31/2008)
    
2. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Updated Meeting Location (Posted: 3/31/2008; Meeting Date: 4/29-30/2008)