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      Archived Info:  Recent FDA Links
                              FDA Links by Classification
 

• 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)
   
• 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)
   
• 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)
   
• Pediatric Research Equity Act of 2007 (PREA) (Posted: 5/5/2008)
   
• 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
      
• Drug Safety Oversight Board Roster (updated 5/2/2008)
   
• Drug Safety Oversight Board Meeting, March 20, 2008 Public Summary (5/2/2008)
   
• The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information (5/2/2008)
   
• Withdrawal of Albumin (Human) 5%, Talecris Biotherapeutics (Posted: 5/1/2008; Withdrawal Date: 4/30/2008)
   
• Workshop: HL7 SPL Working Group Electronic Drug Registration and Listing Meeting - Webinar (Posted: 4/30/2008, Meeting Date: 5/15/2008)
   
• Guidance for Industry: Comprehensive List of Guidance Documents (updated 5/1/2008)
   
• Guidance for Industry: New/Revised/Withdrawn List for 2008 (updated 5/1/2008)
   
• Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 5/1/2008)
   
• Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (updated 4/30/2008)
   
• Drugs@FDA Downloadable Data Files (updated 4/30/2008)
   
• Postmarketing Study Commitments (updated 4/30/2008)
   
• Merck Warning Letter- Questions and Answers (Posted: 4/30/2008)
   
• FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over (4/30/2008)
   
• FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule (4/29/2008)
   
• 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)
   
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 4/29/2008)
   
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update (Posted: 4/28/2008, Updated as of: 4/28/2008)
   
• FDA updates information to healthcare facilities and healthcare professionals about heparin and heparin-containing medical products (4/25/2008)
   
• Postmarketing Study Commitments: Introduction (updated 4/25/2008)
   
• FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation (4/25/2008)
   
• Office of Nonprescription Products: Rx to OTC Switch (updated 4/24/2008)
   
• Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Agenda (Posted: 4/23/2008)
   
• FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease (4/22/2008)
   
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 4/22/2008)
   
• 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)
   
• 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)
   
• Office of Generic Drugs: March First-Time Generic Drug Approvals (4/18/1008)
   
• 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)
   
• 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)
   
• CDER issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg" ( 4/16/2008)
   
• Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) - Alphabetical List of Registered Establishments - Update (Posted: 4/15/2008)
   
• Paragraph IV Patent Certifications (updated 4/15/2008)
   
• 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)
   
• Recent FDA Links
• FDA Links by Classification
  
   

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      Archived Info:  Recently Issued US Federal Register
 

      Archived Info:  Recently Issued FDA Warning Letters
                              Warning Letters Indexed by Company Names
 

• ZymoGenetics, Inc. (Recothrom™ (Thrombin, Topical (Recombinant)))
   
• Zila Pharmaceuticals, Inc. (Peridex® (chlorhexidine gluconate 0.12%) Oral Rinse)
   
• Pfizer, Inc. (Viagra® (sildenafil citrate) Tablets)
   
• Coast Institutional Review Board (Site Inspection)
   
• King Pharmaceuticals, Inc. (Avinza® (morphine sulfate extended-release capsules) CII)
   
• University of Texas Southwestern Medical Center (BMIS Inspection)
   
• Replidyne, Inc. (BMIS Inspection)
   
• Tomita Pharmaceutical Co., Ltd (Site Inspection)
   
• Wyeth Pharmaceuticals, Inc. (Effexor XR^© (venlafaxine HCI) Tablets)
   
• Kalchem International, Inc. (Pharmacy Compounding of Domperidone)
   
• GlaxoSmithKline, Inc. (TYKERB (lapatinib) Tablets)
   
• Recently Issued FDA Warning Letters
• Warning Letters Indexed by Company Names
   

First Page:  Patents/News etc.
(Patents ; News ; Stock Quotes)
 

First Page:  Patents/News etc.
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 New! Training Courses
 New! Web Seminars

• The Drug Development Process – From Discovery to Commercialization  September 17 - 19, 2008, Dublin, Ireland.  Organized by The Center for Professional Innovation & Education.  (Other CfPIE Training Courses)
   
• Advanced Dissolution (Classroom/Online)  Organized by USP (United States Pharmacopeia).  (Other USP Training Courses)
   
• Web Seminar: The Best Approaches to Implement when Analyzing Environmental Microbiology Out-of-Specification (OOS) Data  May 29, 2008.  Speaker: Charles Gyecsek.  Organized by BenAstrum, Inc.  Use promotional code PC0508 for 10% discount. (Other BenAstrum's Web Seminars)
  
 
• Pharmacovigilance and Risk Management Conference  June 18 - 19, 2008, London, UK.   Organized by ViB Events.
   
• 2nd Annual Future of Pharma HR  June 18-19, 2008, Boston, MA.    Organized by Jacob Fleming Conferences.
   
• Pharma 2.0  June 18-20, 2008 Philadelphia, PA.  Organized by the Institute for International Research.
   
• Generic Drugs Summit  June 18-20, 2008 Washington, D.C.  Organized by the Institute for International Research.
   
• Structure-Based Drug Design  June 23-25, 2008, Boston, MA.  Organized by Cambridge Healthtech Institute.
   
• Clinical Trials Supply and Management 2008  June 23 - 25, 2008, Philadelphia, PA.  Organized by IQPC.
   
• Other Pharmaceutical and Biotech Events

 

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