Recent FDA Links
 

1. FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban (7/1/2009)
    
2. Early Communication About Safety of Lantus (insulin glargine) (7/1/2009)
    
3. National Drug Code Directory (updated 7/1/2009)
    
4. Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban (7/1/2009)
    
5. Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) (7/1/2009)
    

1. Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (Updated: 6/30/2009)
    
2. FDA Seeks Public Input on Tobacco Regulation (6/30/2009)
    

1. Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components September 15 - 16, 2009 (6/29/2009)
    
2. Company Recalls Various Products Due to Potential Salmonella Contamination (6/29/2009)
    
3. Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated 6/29/2009)
    
4. Drug Shortages: Resolved Drug Shortages: Metoprolol Succinate extended release tablets (updated 6/29/2009)
    

1. Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (6/26/2009)
    
2. Drug Safety Oversight Board Meeting, Public Summary, May 21, 2009 (6/26/2009)
    
3. BPCA of 2007: List of Determinations including Written Request (6/26/2009)
    

1. Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, July 29, 2009 and July 30, 2009, Silver Spring, Maryland (6/25/2009)
    
2. U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. (6/25/2009)
    
3. Facts About Current Good Manufacturing Practices (cGMPs) (6/25/2009)
    

1. FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under (6/24/2009)
    
2. Drug Shortages: Drugs to be Discontinued: Nandrolone Decanoate Injection (6/24/2009)
    

1. FDA Seeks Public Input on Transparency (6/23/2009)
    
2. First-Time Generic Drug Approvals in May 2009 (6/23/2009)
    

1. U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud (6/19/2009)
    

1. U.S. Attorney News Release: Pharmaceutical Company Manager Sentenced for Off-Label Marketing (6/18/2009)
    

1. Information for Healthcare Professionals: Cefepime (marketed as Maxipime) (6/17/2009)
    
2. Drug Shortages: Drugs to be Discontinued: Inversine (mecamylamine hydrochloride) Tablets, 2.5 mg (6/17/2009)
    
3. Drugs@FDA Download File (updated 6/17/2009)
    

1. FDA Taking Steps to Improve Contact Lens Safety (6/16/2009)
    
2. FDA Advises Consumers Not To Use Certain Zicam Cold Remedies (6/16/2009)
    
3. Clinical Investigator Status (Biologics) (updated 6/16/2009)
    
4. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated 6/16/2009)
    

1. FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims (6/15/09)
    
2. Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD) (6/15/09)
    
3. FDA Issues Public Health Advisory Regarding Levemir Insulin (6/15/09)
    
4. Paragraph IV Patent Certifications (updated 6/15/09)
    

1. Drugs@FDA Download File (updated 6/12/2009)
    

1. Drug Shortages: Current Drug Shortages: Methotrexate injection (updated 6/11/2009)
    
2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 6/11/2009)
    

1. FDA issues a Healthcare Professional sheet on Sirolimus (marketed as Rapamune) (6/10/2009)
    

1. Manual of Policies and Procedures (MaPP) Tracking of Significant Safety Issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issue (Updated 6/9/2009)
    
2. Guidance for Industry: Q8(R1) Pharmaceutical Development Revision 1 (Updated 6/8/2009)
    

1. Guidance for Industry:  Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (Updated 6/8/2009)
    
2. 2009 Meeting Materials, Transmissible Spongiform Encephalopathies Advisory Committee (6/8/2009)
    
3. Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 164KB) (Updated 6/8/2009)
    
4. Complete List of Licensed Products and Establishments (Updated 6/8/2009)
    
5. Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 820KB) (Updated 6/8/2009)
    
6. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 58KB) (Updated 6/8/2009)
    
7. Drug Shortages: Resolved Drug Shortages: Cisplatin Injection 1mg/ml (6/8/2009)
    

1. Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008 (6/4/2009)
    
2. Drug Shortages: Current Drug Shortage: Infed (Iron Dextran) injection (6/4/2009)
    
3. Drug Shortages: Resolved Drug Shortages: Metoprolol Succinate extended release tablets (6/4/2009)
    
4. Investigation of whether the acute hemolysis associated with Rho(D) immune globulin intravenous (human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model (PDF - 150KB) (6/4/2009)
    

1. FDA issues a Healthcare Professional sheet on Propylthiouracil (PTU)-Induced Liver Failure (updated 6/3/2009)
    
2. BPCA/Pediatric Exclusivity Statistics (updated 6/3/2009)
    

1. Guidance for Industry: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application  (updated 6/2/09)
    
2. Paragraph IV Patent Certifications (updated 6/2/09)
    

1. Guidance for Industry (updated 5/28/2009):
   1. Newly Added Bioequivalence Recommendations 21 Newly Added Recommendations.
   2. Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing [PDF]
       
2. Drugs@FDA Downloadable Data Files (updated 5/28/2009)
    
3. National Drug Code Directory Download (updated 5/28/2009)
    

1. Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion [PDF] (updated 5/26/2009)
    
2. FDA updates information for stockpiled antivirals at or nearing expiration. H1N1 Flu (updated 5/26/2009)
    
3. Drug Shortages: Current Drug Shortage: Technetium Tc99m Generators (updated 5/26/2009)
    

1. Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting (PDF, 5/22/2009)
    

1. Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated 5/21/2009)
    
2. Drug Shortages: Current Drug Shortage: Technetium Tc99m Generators (5/21/2009)
    

1. FDA updates information for Tamiflu: Dosing recommendations for infants and technical documents (5/20/2009)
    
2. Drug Shortages: Current Drug Shortage: Morphine Sulfate Oral Solution (updated 5/20/2009)
    

1. Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants [PDF] (5/19/2009)
    
2. Manual of Policies and Procedures (MaPP) 7700.2 Review and Conduct of Human Subject Research (5/19/2009)
    

1. Adverse Event Reporting System (AERS) Statistics (updated 5/18/2009)
    
2. Drug Shortages: Current Drug Shortage: Methotrexate injection (updated 5/18/2009)
    
3. Drug Shortages: Resolved Drug Shortage: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection (updated 5/18/2009)
    

1. Drug Shortages: Current Drug Shortage: Dexrazoxane for Injection, Zinecard (updated 5/15/2009)
    

1. Drug Shortages: Current Drug Shortage: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated 5/14/2009)
    

1. 2009 H1N1 Flu Virus - Letter for Sanofi New Building Approval (Posted: 5/13/2009)
    
2. Memorandum of Meeting Minutes: Drug Safety Oversight Board Meeting, Public Summaries, April 16, 2009 (5/13/2009)
    
3. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated 5/13/2009)
    
4. Drug Shortages: Resolved Drug Shortage: Fentanyl transdermal patch (updated 5/13/2009)
    
5. Office of Generic Drugs: April First-Time Generic Drug Approvals (5/13/2009)