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December 16, 2014

  1. FDA announces Pharmacy Compounding Advisory Committee members (12/16/2014)
     
  2. Orange Book (updated 12/16/2014)
    1. Additions/Deletions for Prescription and OTC Drug Product Lists
    2. Orange Book Current Cumulative Supplement (PDF - 1.4MB)
    3. Orange Book Data Files (compressed) (ZIP - 594KB)
       
  3. December 9, 2014 Summary Basis for Regulatory Action - MP Diagnostics HTLV Blot 2.4 (PDF - 303KB) (Posted: 12/16/2014)
     

December 15, 2014

  1. Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter (12/15/2014)
     

December 11, 2014

  1. FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions (12/11/2014)
     
  2. National Drug Code Directory (12/11/2014)
     
  3. Pediatric Exclusivity Statistics (updated) (12/11/2014)
     
  4. Presentation: CDER New Drug Review: 2014 Update (PDF - 1.3MB) (12/11/2014)
     
  5. Presentation: Update From the Office of Surveillance and Epidemiology (PDF - 780KB) (12/11/2014)
     

December 10, 2014

  1. Guidance for Industry: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products – Content and Format (PDF - 91KB) (12/10/2014)
     

December 8, 2014

  1. Draft Guidance: DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers (PDF - 94KB) (12/8/2014)
     
  2. Draft Guidance: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF - 375KB) (12/8/2014)
     
  3. Bacterial Detection Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry (PDF - 220KB) (12/8/2014)
     

December 4, 2014

  1. FDA approves Jakafi (ruxolitinib) to treat patients with a chronic type of bone marrow disease (12/4/14)
     
  2. FDA Drug Info Rounds: USP Salt Policy (December 2014) (12/4/14)
     
  3. Guidance for Industry: How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB) (12/4/14)
     
  4. Pregnancy and Lactation Labeling Final Rule (updated 12/4/14)
     

December 3, 2014

  1. Guidance for Industry: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 209KB) (12/3/14)
     
  2. Pregnancy and Lactation Labeling Final Rule (12/3/14)
     

December 2, 2014

  1. FDA Drug Safety Communication (Spanish (12/2/14)):
    1. La FDA advierte sobre un caso de LMP, una infección cerebral poco común, con el fármaco Tecfidera (dimetilfumarato) para la esclerosis múltiple
    2. La FDA evalúa el tratamiento prolongado con la terapia antiagregante plaquetaria, conforme los datos preliminares de los ensayos indican beneficios, pero también un mayor riesgo de muerte por causas no cardiovasculares
       

December 1, 2014

  1. 2014 Biological License Application Approvals (Updated: 12/1/2014)
     
  2. 2014 Biological License Application Supplement Noteworthy Approvals (Updated: 12/1/2014)
     
  3. 2014 Biological Device Application Approvals (Updated: 12/1/2014)
     
  4. Guidance for Industry:  SUPAC: Manufacturing Equipment Addendum (PDF - 213KB) (12/1/2014)
     
  5. Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated 12/1/2014)
     

November 26, 2014

  1. FDA Drug Safety Podcast: FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate) (11/26/2014)
     

November 25, 2014

  1. Developing and Using Precision Therapies in the “Omics" Era: Generating and Interpreting Evidence for Rare Subsets: FDA-UVA co-sponsor ship workshop, December 12, 2014, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993. Meeting information (11/25/2014)
     
  2. FDA Drug Safety Communication: FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate) (11/25/2014)
     
  3. Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry (11/25/2014)
     

November 24, 2014

  1. Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules (11/24/2014)
     
  2. Baxter Initiates Voluntary Recall Of One Lot Of Highly Concentrated Potassium Chloride Injection In The U.S. Due To Mislabeled Overpouch (11/24/2014)
     
  3. From our perspective: Clinical biomarker qualification (updated 11/24/2014)
     
  4. Public Notification: Super Extreme Accelerator contains hidden drug ingredient (11/24/2014)
     
  5. Public Notification: Bee Thin contains hidden drug ingredient (11/24/2014)
     
  6. Public Notification: Black Storm contains hidden drug ingredient (11/24/2014)
     
  7. Public Notification: Bee Slim contains hidden drug ingredient (11/24/2014)
     

November 21, 2014

  1. CDER Conversations: Drug Trials Snapshot (11/21/2014)
     
  2. Drug Trials Snapshot (11/21/2014)
     
  3. Manual of Policies and Procedures (MAPP) 4000.10 Rev.1 Developing Indication-Specific Guidances (PDF - 106KB) (11/21/2014)
     
  4. FDA Drug Safety Podcast: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death (11/21/2014)
     
  5. Paragraph IV Patent Certifications (updated 11/21/2014)
     

November 19, 2014

  1. Manual of Policies and Procedures (MAPP) Chemistry Review of Question-based Review (QbR) Submissions (PDF - 753KB) (11/19/2014)
     

November 18, 2014

  1. Guidance for Industry (updated 11/18/2014):
    1. Vaginal Microbicides: Development for the Prevention of HIV Infection (PDF - 352KB)
    2. Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
       
  2. Public Meeting on Chagas Disease Patient-Focused Drug Development, April 28, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD. Meeting information (11/18/2014)
     

November 17, 2014

  1. Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death (11/17/2014)
     
  2. Manual of Policies and Procedures (MAPP) 6030.8 Rev.1 INDs: Exception From Informed Consent Requirements for Emergency Research (PDF - 283KB) (11/17/2014)
     
  3. National Drug Code Directory (11/17/2014)
     
  4. Sixth Annual Report on Delays in Approvals of Applications related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2013 (PDF - 2MB) (11/17/2014)
     

November 13, 2014

  1. Public Notification: Mayhem Contains Hidden Drug Ingredients (11/13/2014)
     
  2. Drug Statement: Methylphenidate Hydrochloride Extended Release Tablets (generic Concerta) made by Mallinckrodt and Kudco (11/13/2014)
     
  3. Intranasal administration of tuberculosis vaccine studied in mice (Posted: 11/13/2014)
     
  4. Drug Firm Annual Registration Status (updated 11/13/2014)
     
  5. Drug Firm Annual Registration Status Download File (updated 11/13/2014)
     
  6. National Drug Code Directory (11/13/2014)
     

November 10, 2014

  1. Pediatric Exclusivity Granted (updated 11/10/2014)
     
  2. Pediatric Exclusivity Statistics (updated 11/10/2014)
     
  3. Pediatric Written Requests Issued (updated 11/10/2014)
     

November 6, 2014

  1. Manual of Policies and Procedures (MAPP) 7700.5 Critical Path Innovation Meetings Policy and Procedures (PDF - 997KB) (11/6/2014)
     

November 5, 2014

  1. Guidance for Industry : Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (PDF - 61KB) (11/5/2014)
     
  2. Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets (11/5/2014)
     

November 4, 2014

  1. Manual of Policies and Procedures (MAPP) 7700.1 Management of the Regulatory Science and Review Enhancement Program (PDF - 873KB) (11/4/2014)
     

October 28, 2014

  1. Drug Quality Sampling and Testing Programs (10/28/2014)
     
  2. First-Time Generic Drug Approvals - October 2014 (updated 10/28/2014)
     
  3. Meeting Presentation: Non-clinical Cardiovascular Safety Testing: Moving Forward (PDF - 224KB)
  4.   (10/28/2014)
     

October 27, 2014

  1. Guidance for Industry (updated 10/27/2014):
    1. Comprehensive List of Guidance Documents (PDF - 909KB) (Updated)
    2. New/Revised Withdrawn List for 2014 (PDF - 27KB) (Updated)
       
  2. CDER Conversations: Neonatal Research (10/27/2014)
     
  3. Manual of Policies and Procedures (MAPP) 6020.7 Rev. 1. Foreign Language Labeling (PDF - 69KB) (updated 10/27/2014)
     
  4. MedWatch Safety Alert: Intravia Containers by Baxter: Recall - Particulate Matter (10/27/2014)
     
  5. National Drug Code Directory (updated 10/27/2014)
     
  6. Pediatric List of Determinations Including Written Request (updated 10/27/2014)
     
  7. Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) (updated 10/27/2014)
     

October 24, 2014

  1. Guidance for Industry: Qualification of Biomarker--Galactomannan in studies of treatments of invasive Aspergillosis (PDF - 151KB) (10/24/2014)
     

October 23, 2014

  1. FDA Outreach to the Pediatric Cancer Advocacy Community, November 18, 2014, FDA White Oak Campus, Bldg. 31 The Great Room A, Silver Spring, MD. Meeting information (10/23/2014)


 

   

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