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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)
     

October 22, 2014

  1. Contract Packaging Resources, Inc. Issues a Voluntary Nationwide Recall of Assured Brand Naproxen Sodium Tablets due to Packaging Mix-Up (10/22/2014)
     
  2. Paragraph IV Patent Certifications (updated 10/22/2014)
     

October 21, 2014

  1. Guidance for Industry: Migraine: Developing Drugs for Acute Treatment (PDF - 240KB) (10/21/2014)
     

October 20, 2014

  1. MedWatch Safety Alert: Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter (10/20/2014)
     

October 16, 2014

  1. FDA approves Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF) (10/16/2014)
     
  2. FDA approves Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) (10/16/2014)
     
  3. National Drug Code Directory (10/16/2014)
     
  4. Pediatric Exclusivity Statistics (updated 10/16/2014)
     
  5. Pediatric Spectrum of Diseases/Conditions (updated 10/16/2014)
     
  6. Pediatric Written Requests Issued (updated 10/16/2014)
     

October 15, 2014

  1. Approved Risk Evaluation and Mitigation Strategies (REMS) Page (updated 10/15/2014)
     
  2. Hospira Announces Voluntary Nationwide Recall Of Certain Lots of Several Lifecare Products Due To Potential For Leakage (10/15/2014)
     

October 10, 2014

  1. Public Notification: Sit and Slim II Contains Hidden Drug Ingredients (10/10/2014)
     
  2. Guidance for Industry: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (PDF - 351KB) (10/10/2014)
     

October 8, 2014

  1. Hospira Issues a Voluntary Nationwide Recall of One Lot of Vancomycin Hydrochloride for Injection USP, Equivalent to 1 G Vancomycin (Sterile Powder) Due to Uncontrolled Storage During Transit (10/8/2014)
     
  2. Activities Report of the Generic Drug Program (FY 2014) (updated 10/8/2014)
     
  3. First-Time Generic Drugs Report - September 2014 (10/8/2014)

  4.  

October 7, 2014

  1. Guidance for Industry (10/7/2014):
    1. Critical Path Innovation Meetings (PDF - 73KB)
    2. Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen (PDF - 77KB)
    3. The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements;  Questions and Answers (PDF - 155KB)

       

October 6, 2014

  1. Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Three Lots of Ketorolac Tromethamine Injection, USP, 30mg/Ml Due to Labeling the Product With the Incorrect Expiration Date (10/6/2014)
     
  2. FDA study identifies occurrence and risk factors for TRALI, a post-transfusion respiratory complication, among the U.S. elderly during 2007 through 2011 (10/6/2014)
     

October 1, 2014

  1. GDUFA Information Technology/Informatics Plan FY 2013 – FY 2017 (PDF - 420KB) (10/1/2014)
     
  2. FDA Drug Safety Podcast: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events (10/1/2014)
     
  3. FDA Drug Safety Communication (Spanish): La FDA aprueba cambios en la etiqueta del medicamento para el asma Xolair (omalizumab), los que incluyen la descripción de un riesgo ligeramente mayor de acontecimientos adversos cardíacos y cerebrales (10/1/2014)


 

   

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