Internet for Pharmaceutical and Biotech Communities
| Newsletter | Post Jobs | Advertising |
 
 

 

  

Pharm/Biotech Resources

Outsourcing Guide

Cont. Education

Software/Reports

Training Courses

Web Seminars

Jobs

Buyer's Guide

Home Page

Pharm Patents /
Licensing

Pharm News

Federal Register

Pharm Stocks

FDA Links

FDA Warning Letters

FDA Doc/cGMP

Pharm/Biotech Events

Consultants

Advertiser Info

Newsletter Subscription

Web Links

Suggestions

Site Map
 

 
   

 

  FDA Links  

FDA Links -- Drug Information
 

 New! Pharm/Biotech Web Seminars
 New! 
Woodbury College's Master of Science in Law
 New! Pharm/Biotech Jobs
 New! 
George Washington University's Healthcare MBA
 New! Pharmaceutical/Biotech Outsourcing Companies
 New! 
Executive MBA in Pharmaceutical Management
 New! 
Pharmaceutical Operation Software
 New! 
Pharmaceutical Business Intelligence Studies
 New! 
Free Pharm/Biotech Magazine Subscription
 New! Pharm/Biotech Training Courses
 
  1. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (5/14/2008)
     
  2. Drugs@FDA Downloadable Data Files (updated 5/14/2008)
     
  3. Drug Shortage: Digitek (digoxin tablets, USP) (5/12/2008)
     
  4. Office of Generic Drugs: April First-Time Generic Drug Approvals (5/9/2008)
     
  5. Office of Generic Drugs: March First-Time Generic Drug Approvals (4/18/1008)
     
  6. Paragraph IV Patent Certifications (updated 4/15/2008)
     
  7. The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated 4/11/08)
     
  8. New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated 4/10/2008)
     
  9. Dissolution Methods Database (updated 4/9/2008)
     
  10. Drugs@FDA Downloadable Data Files (updated 4/9/2008)
     
  11. Drug Shortages (updated 4/7/2008)
    1. Current Drug Shortage: Neupro (rotigotine transdermal system)
    2. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg
       
  12. National Drug Code Directory Download (updated 4/4/2008)
     
  13. National Drug Code Directory Search (updated 4/4/2008)
     
  14. Resolved Drug Shortage: BiCNU (updated 4/2/2008)
     
  15. Drugs@FDA Downloadable Data Files (updated 4/2/2008)
     
  16. CDER Data Standards Manual: SPL Flavor (4/2/2008)
     
  17. Dissolution Methods Database (updated 3/13/2008)
     
  18. Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book (updated 3/13/2008)
     
  19. Drug Approval Reports (updated 3/13/2008)
    1. NDA and BLA Approvals
    2. NME Drug and New Biologic Approvals
    3. Priority NDA and BLA Approvals
       
  20. FDA updates screening method for heparin: Impurity Evaluation of Heparin Sodium by 1H-NMR Spectroscopy (PDF, 3/11/2008)
     
  21. National Drug Code Directory Download (updated 3/5/2008)
     
  22. National Drug Code Directory Search (updated 3/5/2008)
     
  23. Drug Safety Oversight Board Meeting, February 21, 2008, Public Summary (3/4/2008)
     
  24. Drug Shortages (Update, 3/3/2008)
    1. Fentanyl transdermal patch
    2. Heparin sodium injection multidose and single dose vials, heparin flush products from Baxter
       
  25. Drug Shortage (2/29/2008)
    1. Drug to be Discontinued: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection
       
  26. Drug Shortage (2/28/2008)
    1. Drug to be Discontinued: Tenormin (atenolol) 0.5mg/ml Injection
       
  27. Drug Shortages (Posted 2/26/2008)
    1. Drug to be Discontinued: Teslac (testolactone tablets, USP) 50mg tablets
       
  28. Drug Shortages (updated 2/20/2008)
    1. Current Shortage: Baxter 1000u/mL heparin vials in 10mL and 30mL sizes
    2. Drug to be Discontinued: Zyflo (zileuton) tablets
       
  29. Drugs@FDA Downloadable Data Files (updated 2/20/2008)
     
  30. Acronyms and Abbreviations Database Download File (updated 2/15/2008)
     
  31. Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book (updated 2/15/2008)
     
  32. Duragesic (fentanyl transdermal system) Medication Guide (PDF, 2/13/2008)
     
  33. Drug Approval Reports (2/12/2008)
    1. NDA and BLA Approvals (updated)
    2. NME Drug and New Biologic Approvals (updated)
    3. Priority NDA and BLA Approvals (updated)
    4. Efficacy Supplement Approvals (updated)
    5. New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
       
  34. Office of Generic Drugs: January First-Time Generic Drug Approvals (updated 2/11/2008)
     
  35. Adverse Event Reporting System (AERS) Latest Quarterly Data Files (2/7/2008)
     
  36. Drug to be Discontinued: Humatin (Paromomycin Sulfate Capsules, USP) (2/7/2008)
     
  37. Drug Shortage: Resolved; Tikosyn (0.5mg and 0.25mg capsules) (2/5/2008)
     
  38. Drug Master Files (updated 1/29/2008)
     
  39. Drug Shortages (1/23/2008)
    1. Current Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial containing EDTA
    2. Resolved Drug Shortage: Amytal (amobarbital sodium) injection Company Information
       
  40. Inactive Ingredients for Approved Drug Products (Search) (updated 1/15/2008)
     
  41. Inactive Ingredients for Approved Drug Products (Download) (updated 1/15/2008)
     
  42. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) (updated 1/15/2008)
     
  43. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated 1/11/2008)
     
  44. Bioresearch Monitoring Information System (BMIS) File (updated 1/11/2008)
     
  45. Bioresearch Monitoring Information System (BMIS) Search (updated 1/11/2008)
     
  46. National Drug Code Directory Download (updated 1/4/2008)
     
  47. National Drug Code Directory Search (updated 1/4/2008)
     
  48. Resolved Drug Shortage: Tc99: Multiple diagnostic products which utilize Tc99 generators (1/4/2008)
     
  49. Office of Generic Drugs: November First-Time Generic Drug Approvals (updated 12/19/2007)
     
  50. Adverse Drug Experience Reporting (updated 12/18/2007)
     
  51. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection (12/14/2007)
     
  52. Questions and Answers on Sapropterin (Kuvan) (12/13/2007)
     
  53. Dissolution Methods Database (updated 12/5/2007)
     
  54. Drug Shortage: Drug to be Discontinued; Roferon-A (Interferon alfa-2a, Recombinant) (11/29/2007)
     
  55. Drugs@FDA Downloadable Data Files (updated 11/28/2007)
     
  56. Drug Shortage: Resolved (11/21/2007)
    1. Indocyanine Green for Injection, USP (IC-GREEN)
    2. Solu-Cortef 100mg (hydrocortisone sodium succinate) for injection
       
  57. Office of Generic Drugs: October First-Time Generic Drug Approvals (11/16/2007)
     
  58. Drug Approval Reports (updated 11/14/2007)
    1. NDA and BLA Approvals
    2. NME Drug and New Biologic Approvals
    3. Priority NDA and BLA Approvals
       
  59. Drug Approval Reports: Efficacy Supplement Approvals (11/13/2007)
     
  60. Drug Shortage
    1. Drug to be Discontinued; Procanbid (Procanamide Hydrochloride Extended-Release Tablets) (11/9/2007)
       
  61. Drug Approval Reports (Updated 11/9/2007)
    1. Fast Track Fiscal Year 2007
    2. Fast Track Designation (FY 1998 - FY 2006)
    3. NDA and BLA Approvals
    4. NME Drug and New Biologic Approvals
    5. Priority NDA and BLA Approvals
       
  62. CellCept (mycophenolate mofetil) - Changes to prescribing information due to increased risk of first trimester pregnancy loss and increased risk of congenital malformations (10/29/2007)
     
  63. Drug Shortage
    1. Drug to be Discontinued; Exubera (insulin recombinant human, powder for inhalation)
    2. Current Shortage: Valstar (valrubicin) Solution for Intravesical Instillation (updated 10/19/2007)
       
  64. Paragraph IV Patent Certifications (updated 10/19/2007)
     
  65. Bioresearch Monitoring Information System (BMIS) download file (Updated 10/18/2007)
     
  66. Drug Approval Report: Accelerated Approvals (Updated 10/18/2007)
     
  67. Office of Generic Drugs: First-Time Generic Drug Approvals (updated 10/17/2007)
     
  68. AERS Quarterly Download, 2nd Quarter 2007 (updated 10/16/2007)
     
  69. FDA Acronyms Search (updated 10/15/2007)
     
  70. Dissolution Methods Database (updated 10/12/2007)
     
  71. Drug Master Files (updated 10/12/2007)
     
  72. Drug Shortage: Drug to be Discontinued; Sporanox (10/12/2007)
     
  73. Drug Shortage: Drug to be Discontinued; Agenerase (amprenavir) 150mg capsule (updated 10/10/2007)
     
  74. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
     
  75. Drugs@FDA Downloadable Data Files (updated 10/10/2007)
     
  76. Current Drug Shortage
    1. Solu-Cortef 100mg (Hydrocortisone sodium succinate) for injection (updated 10/9/2007)
    2. Valstar (valrubicin) Solution for Intravesical Instillation (updated 10/9/2007)
       
  77. Prescription Drug User Fee Act (PDUFA) Billable Products (PDF, updated 9/28/2007)
     
  78. Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets (updated 9/17/2007)
     
  79. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (9/13/2007)
     
  80. Drug Safety Oversight Board Meeting Public Summaries for May and July (8/10/2007)
     

 

   


Hit Counter

     
[ Outsourcing Guide ] [ Cont. Education ] [ Software/Reports ] [ Training Courses ]
[ Web Seminars ] [ Jobs ] [ Consultants ] [ Buyer's Guide ] [ Advertiser Info ]

[ Home ] [ Pharm Patents / Licensing ] [ Pharm News ] [ Federal Register ]
[ Pharm Stocks ] [ FDA Links ] [ FDA Warning Letters ] [ FDA Doc/cGMP ]
[ Pharm/Biotech Events ] [ Newsletter Subscription ] [ Web Links ] [ Suggestions ]
[ Site Map ]