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  1. Guidance for Industry:  FDA Regulation of PET Drug Products Questions and Answers (PDF - 1040KB) (updated 2/2/2012)
     
  2. Medication Guides (updated 2/2/2012)
     

February 1, 2012
  1. FDA approves Gleevec (imatinib) for expanded use in patients with rare gastrointestinal cancer (2/1/2012)
     
  2. Pediatric List of Determinations Including Written Request (updated 2/1/2012)
     
  3. Drugs@FDA Download File (updated 2/1/2012)
     
  1. FDA approves Kalydeco to treat rare form of cystic fibrosis (1/31/2012)
     
  2. The Role of CBER in the Success against Epidemic Meningitis in Africa - MenAfriVac (PDF - 295KB) (Posted: 1/31/2012)
     
  3. Genomics News and Upcoming Events (updated 1/31/2012)
     
  4. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 1/31/2012)
     
  1. MedWatch Safety Alert: Treanda (bendamustine HCL): Recall - Particulate Matter in Vial (1/30/2012)
     
  2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 1/30/2012)
     
  1. FDA Press Release: Department of Justice files consent decree of permanent injunction against Ranbaxy (1/26/2012)
     
  2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 1/26/2012)
     
  1. eCTD: FDA Portable Document Format (PDF) Specifications (1/25/2012)
     
  2. Attention Deficit Hyperactivity Disorder (ADHD): Not Just for Kids (1/25/2012)
     
  3. FDA Drug Safety Podcast for Healthcare Professionals: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab) (1/25/2012)
     

January 24, 2012
  1. Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB) (updated 1/24/2012)
     
  2. 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)
     
  3. Paragraph IV Patent Certifications (updated 1/24/2012)
     
  1. Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB) (Posted: 1/18/2012)
     
  2. 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)
     
  3. FDA approves Voraxaze (glucarpidase) to treat patients with toxic methotrexate levels (1/18/2012)
     
  4. Inactive Ingredients Database Download (updated 1/18/2012)
     
  5. National Drug Code Directory (updated 1/18/2012)
     

  1. The Adverse Event Reporting System (AERS): Latest Quarterly Data Files (updated 1/17/2012)
     

  1. Notice of Risks of Purchasing Unapproved Injectable Cancer Medications (PDF - 31KB) (1/13/2012)
     
  2. 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)
     
  3. FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin) (1/13/2012)
     
  4. FDA Drug Safety Podcast for Healthcare Professionals: Update- Preliminary findings from ongoing investigations of CardioGen-82 (1/13/2012)
     
  6. Publications on Genomics (updated 1/13/2012)
     

January 11, 2012
  1. Transcript: Public Meeting on Proposed Recommendations for a Human Generic Drug User Fee (PDF - 276KB) (1/11/2012)
     
  2. Office of Generic Drugs: Chemistry and Bioequivalence Review Teams (updated 1/11/2012)
     
  3. Suitability Petitions (updated 1/11/2012)
     
  4. Drugs@FDA Download File (updated 1/11/2012)
     
  5. First-Time Generic Drug Approvals - December 2011 (updated 1/11/2012)
     

January 9, 2012
  1. Certain Opiate Products Made for Endo Pharmaceuticals (1/9/2012)
     
  2. Drug Firm Annual Registration Status (updated 1/9/2012)
     
  3. Drug Firm Annual Registration Status Download File (ZIP - 380KB) (updated 1/9/2012)
     
  1. Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 1/5/2012)
     
  2. Electronic Common Technical Document (eCTD) (updated 1/5/2012)
     
  3. eCTD Validation Specifications (updated 1/5/2012)
     
  4. FDA Statement on recently terminated clinical trial with Doribax (doripenem) (1/5/2012)
     
  5. Office of Prescription Drug Promotion (OPDP) (updated 1/5/2012)
     
  6. OPDP Research (updated 1/5/2012)
     
  1. Guidance for Industry (updated 1/4/2012):
    1. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
    2. Comprehensive List (Research List) of CDER Guidance Documents (PDF - 650KB)
    3. New, Revised, Withdrawn List of CDER Guidance Documents (PDF -120KB)
       
  2. Comunicaciones de la FDA sobre la seguridad de los medicamentos en español (1/4/2012)
    1. Comunicado de la FDA sobre la seguridad de los medicamentos: El uso de antidepresivos con inhibidor selectivo de recaptación de serotonina (SSRI por sus siglas en inglés) durante el embarazo y reportes de afecciones cardiacas y pulmonares poco comunes en recién nacidos
       
  3. Manual of Policies and Procedures (MAPP) 4141.2 (PDF -100KB) Tracking of Significant Safety issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issues (updated 1/4/2012)
     
  4. National Drug Code Directory Data File Download (updated 1/4/2012)
     
  1. ANDA Filing Checklist for Completeness and Acceptability (PDF - updated 1/3/2012)
     
  2. Drug Firm Annual Registration Status (updated 1/3/2012)
     
  3. Drug Firm Annual Registration Status Download File (ZIP - 384KB) (updated 1/3/2012)
     

December 30, 2011
  1. Medication Guides (updated 12/30/2011)
     

December 29, 2011
  1. Guidance for Industry: Use of Histology in Biomarker Qualification Studies (PDF - 298KB) (12/29/2011)
     
  2. Questions and Answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines (12/29/2011)
     
  1. FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal (12/28/2011)
     
  2. Drug Development Tools (DDT) Qualification Program (12/28/2011)
     
  3. Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirement for Manufacturers of Human Cells, Tissues, adn Cellular and Tissue-Based Products (HCT/Ps) (PDF - 371KB) (Posted:12/28/2011)
     

December 27, 2011
  1. Guidance for Industry:  Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 258KB) (12/27/2011)
     
  1. Manual of Policies and Procedures (MAPP)  6002.4 Government-Issued Nonaccountable Personal Property (PDF - 110KB) (12/23/2011)
     

December 22, 2011
  1. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Transcript (PDF - 756KB) (Posted:12/22/2011)
     
  2. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Final Public Roster (Posted:12/22/2011)
     
  3. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Final Agenda (PDF - 20KB) (Posted:12/22/2011)
     
  4. November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Presentations (Posted:12/22/2011)
     
  5. Comunicaciones de la FDA sobre la seguridad de los medicamentos en español (Posted:12/22/2011)
    1. Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización del estudio de seguridad de medicamentos usados para tratar el Trastorno de Deficiencia de Atención e Hiperactividad (ADHD por sus siglas en inglés) en adultos
    2. Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad de informes posteriores al lanzamiento al mercado sobre eventos de hemorragias severas con el anticoagulante Pradaxa (dabigatrán etexilato mesilato)
    3. Comunicado de la FDA sobre la seguridad de los medicamentos: Modificación a la limitación de dosis para Zocor (simvastatina) cuando se toma con amiodarona
       
  6. FDA expands use of HIV drug Isentress to children and adolescents (Posted:12/22/2011)
     
  1. Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants Research Summary (Posted:12/21/2011)
     
  2. FDA Drug Safety Podcast for Healthcare Professionals: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events (Posted:12/21/2011)
     
  3. Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Production and Process Controls (updated 12/21/2011)
     
  1. FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod) (12/20/2011)
     
  2. Webinar on CGMP for PET Drugs (12/20/2011)
     
  3. Bioresearch Monitoring Information System (BMIS) Download File (updated 12/20/2011)
     
  4. Drug Firm Annual Registration Status (updated 12/20/2011)
     
  5. Drug Firm Annual Registration Status Download File (ZIP - 390KB) (updated 12/20/2011)
     
  1. FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events (12/19/2011)
     
  2. Paragraph IV Patent Certifications (updated 12/19/2011)
     
  3. November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript (PDF - 427KB) (Posted:12/19/2011)
     
  1. FDA Drug Safety Podcast for Healthcare Professionals: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone (12/16/2011)
     
  2. Prescription Drug User Fee Act (PDUFA) The FY 2011 Clean-Up Product and Establishment Fee Invoices were mailed Friday, December 16, 2011. Full payment of the invoice is due in 30 days. If you do not receive your invoice by December 23, 2011, please contact Beverly Friedman at 301-796-3602 (12/16/2011)
     
  1. FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone (12/15/2011)
     
  2. PDUFA Meetings: Comments Submitted to the PDUFA Public Meeting Docket (FDA-2010-N-0128) for 10/24/2011 Meeting (12/15/2011)
     
  3. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 12/15/2011)
     

December 14, 2011
  1. FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies (Posted:12/14/2011)
     
  2. September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Hemacord BLA 125397: Hematopoietic Progenitor Cells, Cord (HPC-C) (PPT - 1.7MB) (Posted:12/14/2011)
     
  3. September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Safety Review (PPT - 1.1MB) (Posted:12/14/2011)
     
  4. Orange Book: November 2011: Additions and Deletiions to the Drug Product List (PDF - 101KB) (Updated 12/14/2011)
     
  5. Orange Book Updated (Updated 12/14/2011)

 

    

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