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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 Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products (Posted: 7/9/2014)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)
     

July 2, 2014

  1. Spanish FDA Drug Safety Communications (7/2/2014):
    1. La FDA recomienda no usar lidocaína para el tratamiento del dolor por dentición y requiere nuevo Recuadro de advertencia
    2. No es concluyente el análisis de la FDA de riesgos cardiovasculares para diabéticos que toman el medicamento para la hipertensión olmesartán; se requieren actualizaciones a la etiqueta
       

June 30, 2014

  1. FDA warns health care professionals not to use injectable vitamin products distributed by Medical Supply Liquidators with a Sunshine Labs label (6/30/2014)
     
  2. FDA approves Afrezza (insulin human) to treat diabetes (6/30/2014)
     
  3. Meeting Presentation: Will Government encourage innovation for the development of abuse deterrent formulations? (PDF - 370KB) (6/30/2014)
     

June 27, 2014

  1. FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required (6/27/2014)
     
  2. FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products (6/27/2014)
     

June 26, 2014

  1. FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning (6/26/2014)
     
  2. Spanish FDA Drug Safety Communication: FDA advierte que el medicamento para el cáncer docetaxel puede causar síntomas de intoxicación alcohólica después del tratamiento (6/26/2014)
     

June 25, 2014

  1. CDER Small Business and Industry Assistance (CDER SBIA) Webinar on “An Overview of FDA’s Draft Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” - July 1, 2014 (6/25/2014)
     
  2. FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required (6/25/2014)
     
  3. FDA Drug Safety Podcast: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment (6/25/2014)
     

June 24, 2014

  1. Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014 (PDF - 23KB) (Updated: 6/24/2014)
     

June 23, 2014

  1. FDA approves Sivextro (tedizolid phosphate) to treat skin infections (6/23/2014)
     

June 20, 2014

  1. FDA and Marijuana (6/20/2014)
    1. FDA and Marijuana: Questions and Answers
    2. Marijuana Research with Human Subjects
       
  2. FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment (6/20/2014)
     

June 19, 2014

  1. FDA adding general warning to testosterone products about potential for venous blood clots (6/19/2014)
     

June 18, 2014

  1. Manual of Policies and Procedures (MAPP) 4643.4 CDER Office Space Requests (PDF - 455KB) (updated 6/18/2014)
     
  2. Guidance for Industry:Uncomplicated Gonorrhea: Developing Drugs for Treatment (PDF - 290KB) (updated 6/18/2014)
     
  3. List of Determinations Including Written Request (updated 6/18/2014)
     

June 17, 2014

  1. Guidance for Industry (updated 6/17/2014)
    1. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF - 135KB)
    2. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (PDF - 176KB)
       
  2. Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information (6/17/2014)
     
  3. Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated 6/17/2014)
     

June 16, 2014

  1. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January – March 2014 (6/16/2014)
     

June 13, 2014

  1. Guidance for Industry:  Q4B Annex 6: Uniformity of Dosage Units General Chapter (PDF - 53KB) (6/13/2014)
     

June 11, 2014

  1. Guidance for Industry:  ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 215KB) (6/11/2014)
     

June 10, 2014

  1. Manual of Policies and Procedures (MAPP) 4655.0 Reference Checks (PDF - 167KB) (6/10/2014)
     
  2. Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.3MB) (6/10/2014)
     
  3. Pediatric Medical, Statistical, and Clinical Pharmacology Reviews (updated 6/10/2014)
     
  4. Meeting Presentation: FDA Response to Drug Shortages (PDF - 465KB) (6/10/2014)
     

June 9, 2014

  1. Draft Guidance for Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports (PDF - 117KB) (6/9/2014)
     

June 6, 2014

  1. Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF - 95KB) (6/6/2014)


 

   

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