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 FDA posts one final and one draft guidance for industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits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

August 15, 2014

  1. FDA approves Avastin (bevacizumab) to treat patients with aggressive and late-stage cervical cancer (8/15/2014)
     

August 14, 2014

  1. FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014 (8/14/2014)
     
  2. FDA approves Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia) (8/14/2014)
     

August 13, 2014

  1. Baxter Initiates Voluntary Recall of One Lot of 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solution (8/13/2014)
     
  2. Guidance for Industry (8/13/2014):
  3. Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Considerations, Content, and Format (PDF - 117KB)
  4. Immunogenicity Assessment for Therapeutic Protein Products (PDF - 242KB)
     

August 12, 2014

  1. Meeting Presentation: Office of Pharmaceutical Quality: Global Drug Development and its Impact on CDER’s Drug Review Process Symposium (PDF - 996KB) (8/12/2014)
     

August 11, 2014

  1. Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Following Complaints of Foreign Particulate Matter in Reconstituted Vials (8/11/2014)
     

August 8, 2014

  1. CDER Key Official List (PDF - 125KB) (updated 8/8/2014)
     
  2. Drug Firm Annual Registration Status (updated 8/8/2014)
     
  3. Drug Firm Annual Registration Status Download File (updated 8/8/2014)
     
  4. MedWatch Safety Alert - Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter (8/8/2014)


 

   

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