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  FDA Links  

FDA Links -- About CDER/FDA News

 

 
  1. Realignment in the Office of New Drugs (3/9/2010)
     
  2. Office of Nonprescription Products Consumer Update: Hydroquinone Studies Under The National Toxicology Program (NTP) (3/5/2010)
     
  3. FDA Approves Name Change for Heartburn Drug Kapidex (3/4/2010)
     
  4. Follow-up letters to 6 companies marketing unapproved narcotics containing morphine sulfate (3/4/2010)
     
  5. Manual of Policies and Procedures (CDER MaPP) 7400.11 Management of the PTCC Nonclinical Biologics Subcommittee (PDF - 54 KB) (3/4/2010)
     
  6. FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland (3/3/2010)
     
  7. Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 3/1/2010)
     
  8. FDA Expands Commitment to Patients with Rare Diseases (2/25/2010)
     
  9. FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms (2/23/2010)
     
  10. Drug Safety Oversight Board Meeting, Public Summary, January 21, 2010 (2/22/2010)
     
  11. FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety (2/22/2010)
     
  12. MedWatch Alert - Exjade (deferasirox): Boxed Warning (2/19/2010)
     
  13. Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs) (2/18/2010)
     
  14. FDA Drug Safety Communication: New safety requirements for Long-Acting Inhaled Asthma Medications called Long-Acting Beta-Agonists (LABAs) (2/18/2010)
     
  15. FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products (2/17/2010)
     
  16. FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp (2/16/2010)
     
  17. Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial (2/8/2010)
     
  18. FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab) (2/5/2010)
     
  19. FDA approves Xiaflex (collagenase clostridium histolyticum) for debilitating hand condition (2/3/2010)
     
  20. First-Time Generics - December 2009 (Updated: 2/3/2010)
     
  21. Postmarket Requirements and Commitments Database (updated 2/2/2010)
     
  22. MedWatch Alert - Zyprexa (olanzapine): Use in Adolescents (2/1/2010)
     
  23. FDA issued a Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine) (1/29/2010)
     
  24. Initiatives (Center for Drug Evaluation and Research) (1/28/2010)
     
  25. MedWatch Alert - Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment (1/26/2010)
     
  26. FDA approves Ampyra (dalfampridine) extended release tablets to improve walking in adults with multiple sclerosis (1/25/2010)
     
  27. UPDATED Public Health Alert: Counterfeit Alli containing sibutramine (1/22/2010)
     
  28. MedWatch Alert: Alli 60 mg capsules (120 count refill kit): Counterfeit product (1/19/2010)
     
  29. The Adverse Event Reporting System (AERS): Latest Quarterly Data Files (updated 1/19/2010)
     
  30. Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating (Posted: 1/15/2010)
     
  31. PREA Retrospective Review (PDF - 281KB) (1/14/2009)
     
  32. Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler) (1/14/2009)
     
  33. Fast Track Designation Request Performance (Updated: 1/12/2009)
     
  34. MedWatch Alert - Rapamune (sirolimus): Drug Monitoring Recommendations (1/11/2010)
     
  35. Presentations from Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (November 12-13, 2009) (Posted 12/31/2009)
     
  36. FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy (12/31/2009)
     
  37. MedWatch Alert: Tylenol Arthritis Pain Caplet, 100 count bottles - Recall of all lots (Updated: 12/29/2009)
     
  38. Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - FDA Investigates a Report from the SEAS Trial (12/22/2009)
     
  39. Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir IV Under EUA (updated 12/18/2009)
     
  40. Drug Safety Oversight Board Meeting, Public Summary, November 16, 2009 (12/16/2009)
     
  41. Public Health Advisory: Availability of Tamiflu for Oral Suspension (12/14/2009)
     
  42. December 15, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents  Roster and Draft Agenda posted (Posted: 12/11/2009)
     
  43. New Drug Review: 2009 Update, presentation by John K. Jenkins, M.D. Director, Office of New Drugs (PDF - 514 KB) (12/10/2009)
     
  44. MedWatch Alert: Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging (12/10/2009)
     
  45. Positron Emission Tomography (PET)  (Updated 12/9/2009)
     
  46. Prescription Drug User Fee Act: FY 2009 Clean-up Product and Establishment Fee Invoices were mailed on 12/9/2009  (Updated 12/9/2009)
     
  47. Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 12/8/2009)
     
  48. Manual of Policies and Procedures (MaPP) 4657.3 (PDF - 217 KB)  Overtime Policy (updated 12/8/2009)
     
  49. MedWatch Alert: Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes (12/8/2009)
     
  50. FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema (12/3/2009)
     
  51. FDA Drug Safety Newsletter - Volume 2, Number 3, 2009 (12/3/2009)
     
  52. Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate (12/3/2009)
     
  53. MedWatch Alert for Norpramin (desipramine hydrochloride) (12/2/2009)
     
  54. FDA’s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine (11/30/2009)
  55.  
  56. Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which FDA Has Issued A Written Request For Pediatric Studies Under The Best Pharmaceuticals For Children Act (BPCA) (updated 11/27/2009)
     
  57. Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride) (11/20/2009)
     
  58. Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations (11/20/2009)
     
  59. MedWatch Safety Alert: Vicks Sinex Nasal Spray - Recall (11/20/2009)
     
  60. Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS) (updated 11/20/2009)

   

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