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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)
     

September 30, 2014

  1. CDER Small Business and Industry Education Series (9/30/2014)
    1.  Engaging with the FDA During New Drug Development
       

September 29, 2014

  1. Manual of Policies and Procedures (MAPP) 7600.11 CDER System of Record, (PDF - 104KB) (9/29/2014)
     
  2. Drug Firm Annual Registration Status (updated 9/29/2014)
     
  3. Drug Firm Annual Registration Status Download File (updated 9/29/2014)
     
  4. FDA warns consumers not to use Eu Yan Sang (Hong Kong) Ltd.’s “Bo Ying compound" (9/29/2014)
     

September 25, 2014

  1. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between April – June 2014 (9/25/2014)
     

September 23, 2014

  1. Know Your Source: Protecting Patients from Unsafe Drugs (9/23/2014)
     
  2. Report: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) (PDF - 207KB) (9/23/2014)
     

September 22, 2014

  1. Bioequivalence Recommendations for Specific Products: Estradiol; Vaginal, Cream (Draft) (PDF - 54KB) (9/22/2014)
     

September 19, 2014

  1. FDA approves Trulicity (dulaglutide) to treat type 2 diabetes in adults (9/19/2014)
     

September 18, 2014

  1. Manual of Policies and Procedures (MAPP) (9/18/2014)
    1. 4000.1 Rev.4 Developing and Issuing MAPPs for CDER (PDF - 115KB)
    2. 4643.2 CDER Copier Management Program (PDF - 64KB)
       
  2. MedWatch Safety Alert - Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling (9/18/2014)
     

September 17, 2014

  1. Small Business and Industry Education Series (9/17/2014) 
    1. Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND
       

September 16, 2014

  1. FDA approves Movantik (naloxegol) for opioid-induced constipation (9/16/2014)
     
  2. FDA posts one final and one draft guidance for industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (9/16/2014)
     
  3. Guidance for Industry (9/16/2014):
  4. ANDA Submissions — Refuse to Receive for Lack of Proper Justification of Impurity Limits (PDF - 81KB)
  5. ANDA Submissions — Refuse-to-Receive Standards (PDF - 229KB)
     

September 15, 2014

  1. Public Notification: Japan Hokkaido Slimming Weight Loss Pills Contain Hidden Drug Ingredients (9/15/2014)
     
  2. Public Notification: Mezo Contains Hidden Drug Ingredient (9/15/2014)
     
  3. Public Notification: LX1 Contains Hidden Drug Ingredient (9/15/2014)
     
  4. Public Notification: Best Line Suplemento Alimenticio Capsules Contains Hidden Drug Ingredient (9/15/2014)
     

September 12, 2014

  1. Hospira Issues a Voluntary Nationwide Recall of One Lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 Ml, Due to Particulate Matter (9/12/2014)
     

September 11, 2014

  1. FDA approves weight-management drug Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) (9/11/2014)
     
  2. Drug Firm Annual Registration Status (updated 9/11/2014)
     
  3. Drug Firm Annual Registration Status Download File (updated 9/11/2014)
     

September 10, 2014

  1. Development and Regulation of Abuse-Deterrent Opioid Medications; Public Meeting, October 30-31, 2014, Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. Meeting information (9/10/2014)
     

September 9, 2014

  1. FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas (9/9/2014)
     
  2. CBER Key Staff Directory (Updated: 9/9/2014)
     
  3. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (9/9/2014)


 

   

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