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      Archived Info:  Recent FDA Links
                              FDA Links by Classification
 

• Guidance for Industry:  FDA Regulation of PET Drug Products Questions and Answers (PDF - 1040KB) (updated 2/2/2012)
   
• Medication Guides (updated 2/2/2012)
   
• FDA approves Gleevec (imatinib) for expanded use in patients with rare gastrointestinal cancer (2/1/2012)
   
• Pediatric List of Determinations Including Written Request (updated 2/1/2012)
   
• Drugs@FDA Download File (updated 2/1/2012)
   
• FDA approves Kalydeco to treat rare form of cystic fibrosis (1/31/2012)
   
• The Role of CBER in the Success against Epidemic Meningitis in Africa - MenAfriVac (PDF - 295KB) (Posted: 1/31/2012)
   
• Genomics News and Upcoming Events (updated 1/31/2012)
   
• BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 1/31/2012)
   
• MedWatch Safety Alert: Treanda (bendamustine HCL): Recall - Particulate Matter in Vial (1/30/2012)
   
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 1/30/2012)
   
• FDA Press Release: Department of Justice files consent decree of permanent injunction against Ranbaxy (1/26/2012)
   
• eCTD: FDA Portable Document Format (PDF) Specifications (1/25/2012)
   
• Attention Deficit Hyperactivity Disorder (ADHD): Not Just for Kids (1/25/2012)
   
• FDA Drug Safety Podcast for Healthcare Professionals: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab) (1/25/2012)
   
• Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB) (updated 1/24/2012)
   
• Manual of Policies and Procedures (MAPP) 6730.1 (PDF - 64KB) Use of Review Templates in the Office of Surveillance and Epidemiology (updated 1/24/2012)
   
• Paragraph IV Patent Certifications (updated 1/24/2012)
   
• Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB) (Posted: 1/18/2012)
   
• Drug Innovation: An ongoing update of FDA’s Center for Drug Evaluation and Research's novel drug approvals of calendar year 2012 (1/18/2012)
   
• FDA approves Voraxaze (glucarpidase) to treat patients with toxic methotrexate levels (1/18/2012)
   
• Inactive Ingredients Database Download (updated 1/18/2012)
   
• National Drug Code Directory (updated 1/18/2012)
   
• The Adverse Event Reporting System (AERS): Latest Quarterly Data Files (updated 1/17/2012)
   
• Notice of Risks of Purchasing Unapproved Injectable Cancer Medications (PDF - 31KB) (1/13/2012)
   
• FDA/Drug Information Association (DIA) Cardiovascular Safety and State-of-the-art Development Issues, April 17-18, 2012, Washington Marriott, 1221 22nd St. NW, Washington, DC 20037 Meeting information (1/13/2012)
   
• FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin) (1/13/2012)
   
• FDA Drug Safety Podcast for Healthcare Professionals: Update- Preliminary findings from ongoing investigations of CardioGen-82 (1/13/2012)
   
• FDA completes work on three drug user fee programs (1/13/2012)
   
• Recent FDA Links
• FDA Links by Classification
   

      Archived Info:  Recently Issued US Federal Register
 

      Archived Info: 
     Recently Issued FDA Warning/Notice of Violation Letters
     Warning/Notice of Violation Letters Indexed by Company Names
 

• Novartis Oncology (Gleevec (imatinib mesylate) tablets for oral use)
   
• Celgene Corporation (Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound))
   
• Dr. Reddy's Laboratories, Inc. (Fondaparinux Sodium Solution for subcutaneous injection)
   
• Mutual Pharmaceutical Company, Inc. (Colcrys (colchicine, USP) tablets for Oral use)
   
• Sunovion Pharmaceuticals, Inc. (Latuda (lurasidone HCl) Tablets)
   
• NeurogesX, Inc. (Qutenza (capsaicin) 8% patch)
   
• Novartis International AG (Manufacture of Finished Pharmaceuticals)
   
• EUSA Pharma (USA), Inc. (ProstaScint Kit (Capromab Pendetide))
   
• Jenahexal Pharm GmbH (Manufacture of Finished Pharmaceuticals)
   
• Recently Issued FDA Warning Letters
• Warning Letters Indexed by Company Names
   

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

 New! Training Courses
 New! Web Seminars

• The Drug Development Process - From Discovery to Commercialization  March 14 – 16 , 2012, Berlin, Germany.  Organized by The Center for Professional Innovation & Education. (Other CfPIE Training Courses)
   
• ON-DEMAND Recorded Webinar: Elemental Impurities Overview  Organized by USP (United States Pharmacopeia). (Other USP Training Courses)
   
• MAGI's Clinical Research Conference - 2012 EAST  May 20 - 23, 2012, Arlington, VA.  Organized by iiBIG (International Institute for Business Information & Growth LLC).
   
• Pharma Outsourcing & Procurement Summit 2012  May 21 - 22, 2012, Berlin, Germany.   Organized by World Trade Group.
   
• The 7th Annual World Health Care Congress-Europe  May 23 - 24, 2012, Amsterdam, Netherlands..  Organized by World Congress.
   
• The 3rd Annual World Congress of NeuroTalk  May 25-28, 2012, Beijing, China.  Organized by BIT World Congress, Inc.
   
• 13th Annual Drug Discovery Leaders Summit  June 11 & 12, 2012, Zurich, Switzerland.  Organized by Oxford Global Conferences.
   
• 4th Annual Drug Development Summit  June 11 & 12, 2012, Zurich, Switzerland.  Organized by Oxford Global Conferences.
   
• 2nd Annual Achieving Clinical & Regulatory Excellence in Turkey, the Middle East & North Africa  June 11 - 14, 2012, Istanbul, Turkey.  Organized by NextLevel Pharma.
   
• The 1st Annual International Symposium of Hematology -2012  June 15-17, 2012, Beijing, China.  Organized by BIT World Congress, Inc.
   
• Other Pharmaceutical and Biotech Events

 

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First Page:  Patents/News etc.
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