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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 FDA posts one final and one draft guidance for industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits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)
     

September 8, 2014

  1. Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (9/8/2014)
     

September 5, 2014

  1. Manual of Policies and Procedures (MAPP) 4190.1 rev. 2 Drug Shortage Management (PDF - 1,098KB) (9/5/2014)
     
  2. National Drug Code Directory (9/5/2014)
     
  3. Guidance for Industry:  Electronic Submission of Lot Distribution Reports (PDF - 62KB) (9/5/2014)
     
  4. CBER is Moving (Updated: 09/05/2014)
     

September 2, 2014

  1. Martin Avenue Pharmacy, Inc. Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (9/2/2014)
     
  2. National Drug Code Directory (9/2/2014)
     

August 28, 2014

  1. CDER Key Officials List (PDF - 125KB) (updated 8/28/2014)
     
  2. Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis (Posted: 8/28/2014)
     

August 27, 2014

  1. Pediatric List of Determinations including Written Request (updated 8/27/2014)
     

August 26, 2014

  1. FDA posts Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (8/26/2014)
     
  2. Draft Guidance: Controlled Correspondence Related to Generic Drug Development (PDF - 113KB) (8/26/2014)
     
  3. New web-based learning course - “Human Drug Establishment Registration and Drug Listing Compliance" (8/26/2014)
     

August 25, 2014

  1. Manual of Policies and Procedures (MAPP) NDAs and BLAs: Communication to Applicants of Planned Review Timelines (PDF - 155KB) (8/25/2014)
     

August 20, 2014

  1. FDA approves Cerdelga (eliglustat), new drug to treat a form of Gaucher disease (8/20/2014)
     

August 19, 2014

  1. FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB) (Updated 8/19/2014)
     

August 18, 2014

  1. Drug Safety Oversight Board Meeting, Public Summary, July 17, 2014 (8/18/2014)
     
  2. MedWatch Safety Alert: Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter (8/18/2014)


 

   

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