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! Pharmaceutical Business Intelligence Studies
 New! PharmCast Research Store
 New! Pharmaceutical Operation Software
 New! Executive MBA in Pharmaceutical Management
 New! Free Pharm/Biotech Magazine Subscription
 New! Pharm/Biotech Training Courses
 New! Pharm/Biotech Jobs
 New! Pharmaceutical/Biotech Outsourcing Companies
 New! Pharm/Biotech Web Seminars
 
 
  1. Presentation: Coming of Age of Personalized Medicine (PDF - 797KB) (5/22/2013)
     
  2. Preventing Surgical Fires: Initiative Partners (updated 5/22/2013)
     

May 21, 2013
  1. MedWatch Safety Alert: Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials (Posted: 5/21/2013)
     
  2. Potential “universal” influenza vaccine developed and tested at FDA (Posted: 5/21/2013)
     
  1. MedWatch Safety Alert: All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance (5/20/13)
     

May 17, 2013
  1. Presentations (5/17/13):
    1. Challenges of Globalization (PDF - 834KB)
    2. Adverse Event Reporting and Medication Safety Considerations: A View from CDER’s Office of Surveillance and Epidemiology (PDF - 445KB)
    3. FDA Perspective: Transformational Initiatives (PDF - 252KB)
    4. The Regulatory Pathway for Rare Diseases Lessons Learned from Examples of Clinical Study Designs for Small Populations (PDF - 832KB)
    5. The Value of A Qualified Outcome Measure (PDF - 41KB)
       
  2. Spanish Drug Safety Communication: Zolpidem: La FDA aprueba cambios de etiqueta para los productos con zolpidem, que incluyen nueva dosificación y una recomendación de evitar conducir el día posterior al uso de Ambien CR (5/17/13)
     
  1. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (Updated: 5/16/13)
     
  2. Medication Guides (Updated: 5/16/13)
     
  3. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (Updated: 5/16/13)
     
  4. Public Workshop: Fecal Microbiota for Transplantation - Presentations (Posted: 5/16/2013)
     
  5. Summary Basis for Regulatory Action, April 19, 2013 - SOLX® System (Posted: 5/16/2013)
     
  6. A mouse model demonstrates a link between transfused UVB irradiated platelets and acute lung injury (Posted: 5/16/2013)
     
  1. FDA Press Release: FDA approves Simponi to treat ulcerative colitis ( 5/15/13)
     
  2. Drug Firm Annual Registration Status (Updated: 5/15/13)
     
  3. Drug Firm Annual Registration Status Download File (Updated: 5/15/13)
     
  4. FDA Drug Safety Podcast: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use (Updated: 5/15/13)
     
  5. National Drug Code Directory (Updated: 5/15/13)
     

May 14, 2013
  1. FDA Press Release: FDA approves Nymalize—first nimpdipine oral solution for use in certin brain hemorrhage patients (5/14/2013)
     
  2. 2013 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee Updated: 5/14/13- added 4/17/13 transcripts and summary minutes (5/14/2013)
     

May 13, 2013
  1. Guidance for Industry: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (PDF - 501KB) (5/13/2013)
     
  2. FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use (5/13/2013)
     
  3. Drug Safety Oversight Board Meeting, March 21, 2013, Public Summary (5/13/2013)
     

May 10, 2013
  1. Pediatric Exclusivity Statistics (updated 5/10/2013)
     

May 9, 2013
  1. FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information (5/9/2013)
     
  2. Paragraph IV Patent Certifications  (updated 5/9/2013)
     
  3. Requesting Speakers from CDER (5/9/2013)
     

May 8, 2013
  1. Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components (Posted: 5/8/2013)
     
  2. AABB Donor History Questionnaire Documents (Posted: 5/8/2013)
     

May 7, 2013
  1. FDA Drug Safety Podcast: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children (Posted: 5/7/2013)
     
  2. Current Drug Shortages Index (updated 5/7/2013)
     
  3. CDER Director's Mailbag Question on Singulair (Posted: 5/7/2013)
     
  4. FDA Drug Safety Podcast: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) (Posted: 5/7/2013)
     
  5. Prescription Drug User Fee Act (PDUFA): The Dear Colleague Letter (PDF - 54KB), in anticipation of FY 2014 Invoices, was mailed Friday, 5/3/2013. Responses are due by 6/12/2013. If you do not receive the letter by 5/31/2013, please contact Ashley Jones or Beverly Friedman at 301-796-3602 (Posted: 5/7/2013)
     
  6. Manual of Policies and Procedures (MAPP) 5000.6R1 Office of Pharmaceutical Science Coordinating Committee (OPS CC) (PDF - 66KB) (Posted: 5/7/2013)
     
  7. FDA discovery that Ad5 vector uses coagulation factor X to block complement proteins has major implications for gene therapy (PDF - 182KB) (Posted: 5/7/2013)
     
  8. Expanded and improved approach to identifying surface protein markers could support development of therapies with human bone marrow multipotent stromal cells (PDF - 262KB) (Posted: 5/7/2013)
     

May 6, 2013
  1. Drug Safety Communication: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) (Posted: 5/6/2013)
     
  2. List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) (Posted: 5/6/2013)
     

May 3, 2013
  1. Spanish Drug Safety Communication: Medicamento anticonvulsivo Potiga (ezogabina) vinculado con anomalías de la retina y decoloración azulada de la piel (5/3/2013)
     

May 2, 2013
  1. FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated 5/2/2013)
     
  2. FAERS Quarterly Data Files Documentation (updated 5/2/2013)
     
  3. National Drug Code Directory (updated 5/2/2013)
     
  4. Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program (Posted: 5/2/2013)
     
  5. Public Workshop: Application of Advances in Nucleic Acid and Protein-Based Detection Methods for Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations Transcripts - April 10, 2013 (PDF - 5.3MB) (Posted: 5/2/2013)
     
  6. Public Workshop: Application of Advances in Nucleic Acid and Protein-Based Detection Methods for Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations Transcripts - April 11, 2013 (PDF - 6.1MB) (Posted: 5/2/2013)
     

May 1, 2013
  1. Notice to Industry: FDA Launches Pilot Project for Electronic Submission of Field Alert Reports (5/1/2013)
     
  2. FDA News Release: FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older (5/1/2013)
     
  3. FDA Drug Safety Podcast: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death (5/1/2013)
     

April 30, 2013
  1. Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death (4/30/2013)
     
  2. MedWatch Safety Alert - Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution (4/30/2013)
     

April 29, 2013
  1. Current Drug Shortages Index (updated 4/29/2013)
     
  2. Manual of Policies and Procedures (MAPP) 6030.9 Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review(PDF - 297KB) (updated 4/29/2013)
     

April 26, 2013
  1. ANDA Suitability Petition Reports (updated 4/26/2013)
     
  2. First-Time Generic Drug Approvals - 2013 (updated 4/26/2013)
     

April 25, 2013
  1. FDA study reinforces no safety concerns from residual formaldehyde in some infant vaccines (Posted: 4/25/2013)
     
  2. Public Notification: “Sex Plus” Contains Hidden Drug Ingredient (4/25/2013)
     
  3. Public Notification: “Zoom-Zooma-Zoom” Contains Hidden Drug Ingredient (4/25/2013)
     
  4. Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 84KB) (4/25/2013)
     

April 24, 2013
  1. MedWatch Safety Alert: All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance (4/24/2013)
     

April 23, 2013
  1. Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF - 608KB) (updated 4/23/2013)
     
  2. Manual of Policies and Procedures (MAPP) 5015.3 Cover Form for the Technical Review of Drug Master Files (DMFs) (PDF - 47KB) (updated 4/23/2013)
     

April 22, 2013
  1. FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy (4/22/2013)
     

April 17, 2013
  1. FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information (4/17/2013)
     
  2. FDA Public Workshop: Clinical Trial Design Issues - Drug & Device Development for Localized Prostate Cancer, May 5, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information (4/17/2013)
     
  3. Guidance for Industry:Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (PDF - 212KB) (4/17/2013)
     

April 16, 2013
  1. FDA Actions on OxyContin Products (4/16/2013) (4/16/2013)
     
  2. FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall (4/16/2013)
     
  3. MedWatch Safety Alert: Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns (4/16/2013)
     
  4. MedWatch Safety Alert: Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns (4/16/2013)
     

April 15, 2013
  1. Drug Firm Annual Registration Status Download File (updated 4/15/2013)
     
  2. Drug Firm Annual Registration Status (updated 4/15/2013)
     
  3. National Drug Code Directory (updated 4/15/2013)
     

April 12, 2013
  1. Guidance for Industry: M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF - 426KB) (4/12/2013)
     
  2. Presentations (4/12/2013):
    1. Drug Induced Liver Injury: Making Decisions, Making Progress (PDF - 285KB)
    2. The Challenges of Globalization (PDF - 1.50MB)
       
  3. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (BPCA/FDASIA) (4/12/2013)
     
  4. MedWatch Safety Alert: Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns (4/12/2013)
     

April 11, 2013
  1. FDA Alerts Healthcare Providers that Drugs Distributed by Shamrock Medical Solutions May be Mislabeled (4/11/2013)
     

April 10, 2013
  1. Current Drug Shortages Index (updated 4/10/2013)
     
  2. Guidance for Industry: Self-Selection Studies for Nonprescription Drug Products (PDF - 160KB) (updated 4/10/2013)
     
  3. Manual of Policies and Procedures (MAPP) CDER Authorization and Tracking of Outside Speaker Clearance (PDF - 141KB) (Revision)  (updated 4/10/2013)
     

April 9, 2013
  1. Small Business Education Series (4/9/2013)
    1. Electronic Common Technical Document (eCTD)
       
  2. Pediatric Statistics (updated 4/9/2013):
    1. Pediatric Exclusivity Statistics (updated)
    2. Spectrum of Diseases/Conditions (updated)
    3. Written Requests Issued (updated)
       

April 8, 2013
  1. Bioresearch Monitoring Information System (BMIS) Search (Posted: 4/8/2013)
     
  2. Clinical Investigator Inspection List (CLIIL) Search (Posted: 4/8/2013)
     
  3. Guidance for Industry: Bioequivalence Recommendations for Specific Products (updated) (updated 4/8/2013)
     
  4. National Drug Code Directory (updated 4/8/2013)
     
  5. Pediatric Statistics: Breakdown of FDAAA Completed Pediatric Studies (updated 4/8/2013)
     
  6. Urgent Field Safety Notice (10699578) OpenGene DNA Sequencing System MicroCel 500 and MicroCel 300 Buffer Chamber Possible Hazard (Posted: 4/8/2013)
     

April 5, 2013
  1. Guidance for Industry: Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF – 183KB) (updated 4/5/2013)
     
  2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated 4/5/2013)
     
  3. Clinical Investigator Status (Biologics) (Posted: 4/5/2013)
     

April 3, 2013
  1. Public Notificaton: “Ninja Mojo” Contains Hidden Drug Ingredient (Posted: 4/3/2013)
     
  2. Public Notification: “Love Rider” Contains Hidden Drug Ingredient (Posted: 4/3/2013)
     
  3. Public Notification: “AFFIRM XL” Contains Hidden Drug Ingredient (Posted: 4/3/2013)
     
  4. Approval History, Letters, Review, and Related Documents - Isoplate Solution (Posted: 4/3/2013)
     

April 2, 2013
  1. Guidance for Industry (Updated: 4/2/2013):
    1. Comprehensive List of Guidance Documents  (PDF - 641KB) 
    2. New Revised Withdrawn List of Guidance Documents  (PDF - 52KB) 
    3. Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 (PDF - 98KB)


 

   

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 ]