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

FDA Links

FDA Warning Letters


Pharm/Biotech Events


Consultants

Advertiser Info

Newsletter Subscription

Web Links

Suggestions

Site Map
 

 
   

 

  FDA Links  

Recent FDA Links
 

 New! Executive MBA in Pharmaceutical Management
 New! Free Pharm/Biotech Magazine Subscription

 New! 
Pharm/Biotech Jobs
 New! 
Pharmaceutical/Biotech Outsourcing Companies
 New! 
Pharm/Biotech Web Seminars
 New!
 Pharm/Biotech Training Courses

 
New!
 Pharmaceutical Business Intelligence Studies
 New! 
PharmCast Research Store
 New! Pharmaceutical Operation Software

 
 

August 20, 2014

  1. FDA approves Cerdelga (eliglustat), new drug to treat a form of Gaucher disease (8/20/2014)
     

August 19, 2014

  1. FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB) (Updated 8/19/2014)
     

August 18, 2014

  1. Drug Safety Oversight Board Meeting, Public Summary, July 17, 2014 (8/18/2014)
     
  2. MedWatch Safety Alert: Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter (8/18/2014)
     

August 15, 2014

  1. FDA approves Avastin (bevacizumab) to treat patients with aggressive and late-stage cervical cancer (8/15/2014)
     

August 14, 2014

  1. FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014 (8/14/2014)
     
  2. FDA approves Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia) (8/14/2014)
     

August 13, 2014

  1. Baxter Initiates Voluntary Recall of One Lot of 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solution (8/13/2014)
     
  2. Guidance for Industry (8/13/2014):
    1. Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Considerations, Content, and Format (PDF - 117KB)
    2. Immunogenicity Assessment for Therapeutic Protein Products (PDF - 242KB)
       

August 12, 2014

  1. Meeting Presentation: Office of Pharmaceutical Quality: Global Drug Development and its Impact on CDER’s Drug Review Process Symposium (PDF - 996KB) (8/12/2014)
     

August 11, 2014

  1. Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Following Complaints of Foreign Particulate Matter in Reconstituted Vials (8/11/2014)
     

August 8, 2014

  1. CDER Key Official List (PDF - 125KB) (updated 8/8/2014)
     
  2. Drug Firm Annual Registration Status (updated 8/8/2014)
     
  3. Drug Firm Annual Registration Status Download File (updated 8/8/2014)
     
  4. MedWatch Safety Alert - Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter (8/8/2014)
     

August 7, 2014

  1. FDA approves Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections (8/7/2014)
     

August 6, 2014

  1. President’s Emergency Plan for AIDS Relief (PEPFAR) (updated with videos) (8/6/2014)
     

August 5, 2014

  1. FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information (8/5/2014)
     
  2. Guidance for Industry: Upper Facial Lines: Developing Botulinum Toxin Drug Products (PDF - 240KB) (8/5/2014)
     
  3. Notice of Public Meeting; Request for Comments: Advancing the Use of Biomarkers and Pharmacogenomics. September 5, 2014. Washington Plaza Hotel, Washington, DC. (8/5/2014)
     

August 4, 2014

  1. Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (PDF - 99KB) (updated 8/4/2014)
     
  2. Manual of Policies and Procedures (MAPP) (updated 8/4/2014)
    1. 5200.4 Criteria and Procedures for Managing the Review of Original ANDAs, Amendments and Supplements (PDF -95KB)
    2. 5240.3 Prioritization of the Review of Original ANDAs, Amendments, and Supplements (PDF - 82KB)
       

August 1, 2014

  1. Patient-Focused Drug Development Public Meeting and Scientific workshop on Female Sexual Dysfunction, October 27-28, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. 20993. Meeting information (8/1/2014)
     

July 30, 2014

  1. Manual of Policies and Procedures (MAPP) 4130.1 Drug Development Tool Qualification Programs (PDF - 275KB) (updated 7/30/2014)
     

July 29, 2014

  1. Approved Risk Evaluation and Mitigation Strategies (REMS) page (updated 7/29/2014)
     
  2. FDA Listing of Authorized Generic Drugs (updated 7/29/2014)
     
  3. Manual of Policies and Procedures (MAPP) 6025.6 Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics (PDF - 285KB) (updated 7/29/2014)
     

July 25, 2014

  1. Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 105KB) (7/25/2014)
     

July 23, 2014

  1. DA approves Targiniq ER with abuse-deterrent properties (7/23/2014)
     
  2. Bioequivalence Recommendations for Specific Products (updated 7/23/2014)
     

July 22, 2014

  1. Public Notification: O.M.G. Contains Hidden Drug Ingredient (7/22/2014)
     
  2. Safe Use Initiative: Funding and Support (updated 7/22/2014)
     
  3. edWatch Safety Alert: Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging (7/22/2014)
     
  4. Exemptions and Alternative Procedures (Updated: 7/22/2014)
     
  5. Individual Case Safety Reports (ICSR) - Specifications (Updated: 7/22/2014)
     

July 18, 2014

  1. FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy) (7/18/2014)
     
  2. Approved Drug Product List - Orange Book: FR Notice Determination of Safety or Effectiveness List (PDF - 387KB) (7/18/2014)
     
  3. Orange Book (updated 7/18/2014)
    1. Additions/Deletions for Prescription and OTC Drug Product Lists
    2. Appendix A: Product Name Index (PDF - 128KB)
    3. Appendix B: Product Name Sorted by Applicant (PDF - 478KB)
    4. Appendix C: Uniform Terms (PDF - 55KB)
    5. Orange Book Current Cumulative Supplement (PDF - 887KB)
    6. Orange Book Data Files (compressed) (ZIP - 577KB) 
       

July 15, 2014

  1. From a Clinical Perspective: Atrial fibrillation and new oral anticoagulant drugs (7/15/2014)
     

July 11, 2014

  1. CBER is Moving (Updated: 7/11/2014)
     

July 10, 2014

  1. DA posts draft guidances describing GDUFA performance metrics and associated webinars (7/10/2014)
     
  2. Guidance for Industry (7/10/2014):
    1. ANDA Submissions — Amendments and Easily Correctable Deficiencies Under GDUFA (PDF -173KB)
    2. ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 231KB)
       

July 9, 2014

  1. Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products (Posted: 7/9/2014)
     
  2. Manual of Policies and Procedures (MAPP) 4657.9 Rev.4 Restoration of Forfeited Annual Leave (PDF - 128KB) (Posted: 7/9/2014)
     

July 7, 2014

  1. Clinical Investigator Training Course, November 4-6, 2014, The Holiday Inn Washington - College Park, MD. Meeting information (7/7/2014)
     
  2. Guidance for Industry (7/7/2014):
    1. Comprehensive List of Guidance Documents (PDF - 271KB)
    2. New Revised Withdrawn List (PDF - 106KB)
       

July 3, 2014

  1. FDA approves Beleodaq (belinostat) to treat rare, aggressive form of non-Hodgkin lymphoma (7/3/2014)
     
  2. Guidance for Industry: Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (PDF - 356KB) (7/3/2014)


 

   

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 ]
[ FDA Links ] [ FDA Warning Letters ] [ Pharm/Biotech Events ]
[ Newsletter Subscription ] [ Web Links ] [ Suggestions ] [ Site Map ]