Charge to the Committee Mark Goldberger, M.D., M.P.H. Director, Office of Drug Evaluation IV CDER / FDA.

Slides:

Advertisements

Similar presentations

Post Research Benefits Mandika Wijeyaratne MS, MD, FRCS Dept. of Surgery, Colombo.

Advertisements

Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer Grant Williams, M.D. Medical Team Leader DODP/CDER/FDA.

Development of the Consumer Professional Partnership Program (CPPP) Thilo Kroll NRH CHDR Steve Towle SCI Network RRTC on SCI: Promoting Health and Preventing.

Safety and Extrapolation Steven Hirschfeld, MD PhD Office of Cellular, Tissue and Gene Therapy Center for Biologics Evaluation and Research FDA.

Single Use Expanded Access IND/IDE: FDA and IRB Requirements Before and After Use IRB Webinar October 9,2014.

Edward P. Sloan, MD, MPH ACEP Clinical Policy Clinical Policy: Critical Issues in the Management of Adult Patients Presenting to the Emergency Department.

G aps, challenges and opportunities Theo Verheij University Medical Center Utrecht Lower Respiratory Tract Infections in Primary Care.

FDA Perspective Sally Loewke, M.D. Acting Division Director

Office of Drug Evaluation IV, CDER FDA/IDSA/ISAP Workshop 4/16/04 Overview of PK-PD in Drug Development Programs: FDA Perspective FDA/IDSA/ISAP Workshop.

Macrolide-Resistant Streptococcus pneumoniae: What is the Public Health Impact? John H. Powers, M.D. Lead Medical Officer Antimicrobial Drug Development.

1 One Year Post-Exclusivity Adverse Event Review: Ertapenem Pediatric Advisory Committee Meeting November 16, 2006 Alan M. Shapiro, MD, PhD, FAAP Medical.

Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and.

Office of Clinical Pharmacology and Biopharmaceutics IDSA/ISAP/FDA Workshop 4/16/04 1 Improvement in Dose Selection: FDA Perspective IDSA/ISAP/FDA Workshop.

IDSA / ISAP / FDA Workshop on Antimicrobial Drug Development Update 2004 Edward Cox, MD MPH ODE IV Center for Drug Evaluation and Research US Food and.

Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science, CDER, FDA ACPS Subcommittee on Manufacturing Science: Identification and Prioritization.

Presented by Lee S. Simon, MD Division Director Analgesic, Anti-inflammatory and Ophthalmology Drug Products ODEV, CDER, FDA at the Arthritis Advisory.

Todays Clinical Trials. Tomorrow’s Cures. Robert L. Comis, MD 1 National Coalition for Cancer Research “Cancer 101” Congressional Briefing 09/10/14.

INDs : Does My Study Need One? Edith Paal UAMS Office of Research Compliance August 22, 2003.

FDA Science Board Drug Safety Initiative April 15, 2005 Rockville, MD RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research.

Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.

Clinical Trials Considerations in Primary Bacteremia due to Staphylococcus aureus Clinical Trials Considerations in Primary Bacteremia due to Staphylococcus.

Expectations of Legislation Bree Collaborative Jason T. McGill, JD Executive Policy Advisor, Health Care Governor's Office (360)

ACPS Meeting, October 19-20, 2004 BioINequivalence: Concept and Definition Lawrence X. Yu, Ph. D. Director for Science Office of Generic Drugs, OPS, CDER,

Joint Meeting of Anti-Infective Drugs & Drug Safety and Risk Management Advisory Committees December 14-15, 2006 Ketek  (telithromycin) Regulatory History.

Evaluating A Systemic Therapy Psoriasis 1.Efficacy 2.Safety 3.Labeling.

Issues with Effectiveness, Resistance and Ethics in Antimicrobial Clinical Trials How We Can Do Better Issues with Effectiveness, Resistance and Ethics.

Community Acquired Pneumonia in the Emergency Department (ED) Emergency Department Nurses & Physicians Dr. Mark Cichon, Director; Bridget Gaughan, Manager.

Pulmonary-Allergy Drugs Advisory Committee May 1, 2007 FDA Presentation Advair Diskus 500/50 Carol Bosken, MD, ScM, MPH Medical Officer Division of Pulmonary.

The New Drug Development Process (www. fda. gov/cder/handbook/develop

Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science Meeting April Quantitative risk analysis using exposure-response.

History of Pediatric Labeling

Antimicrobial Resistance in Streptococcus pneumoniae Implications for Prescription Drug Labeling John H. Powers, MD Lead Medical Officer Antimicrobial.

Answering Clinical Questions at the Point of Care 鄭如雅

Questions to the Committee. Question 1. The Agency has accepted durable responses in hematologic malignancies for approval for both chronic leukemias.

FDA Science Board CDER Drug Safety Update November 6, 2005 Rockville, MD Steven Galson, MD, MPH Director, Center for Drug Evaluation and Research Food.

Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Committee Meeting December 14 & 15, Anti-Infective.

Clinical Trials of Acute Otitis Media John Alexander, M.D., M.P.H. Anti-Infective Drugs Advisory Committee November 7, 2001.

Acute Otitis Media: Lessons Learned Thomas Smith, M.D. Division of Anti-Infective Drug Products.

HIV-1 Resistance Testing in Drug Development Antiviral Drugs Advisory Committee Meeting November 2-3, 1999.

Introduction to the Meeting Introduction to the Meeting Advisory Committee for Pharmaceutical Sciences Clinical Pharmacology Subcommittee November 17-18,

TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drugs Advisory Committee TAXOL® (paclitaxel) for Adjuvant Treatment.

Answering Clinical Questions at the Point of Care

Center for Drug Evaluation and Research March 6, 2005 Bacteremia and Endocarditis: Products and Guidance Janice Soreth, MD Director Division of Anti-Infective.

Anti-Infective Drugs Advisory Committee Meeting September 12, Factive® (gemifloxacin) Proposed for the treatment of Acute Bacterial Sinusitis Oscient.

Advisory Committee for Peripheral and Central Nervous System Drugs March 7, 2006 Question 1: 1.Has Biogen demonstrated natalizumab’s efficacy on reduced.

Nonprescription Drugs Advisory Committee Meeting Charles J. Ganley, M.D. Division of OTC Drug Products September 20, 2002.

Questions to Committee about Potential Cancer Risk with Use of Topical Immunosuppressants (Calcineurin Inhibitors) Question 1: Messages about Risk A. Based.

Ethical issues with the regulatory use of gene expression data Benjamin S Wilfond MD Medical Genetics Branch National Human Genome Research Institute Department.

Acute Bacterial Otitis Media Summary and Charge to the Committee Renata Albrecht, M.D. Division of Special Pathogen and Immunologic Drug Products ODEIV,

21 CFR Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006.

Pharmacogenetics (PGx) of Irinotecan: Scientific and Clinical Impact of UGT Polymorphism: Background Clinical Pharmacology Subcommittee of ACPS November.

Chronic Disease Tracking System  Problem  The current healthcare model focuses on one patient at a time in the office.  Chronic disease leads to higher.

Complaint and recall 1. Title 21--food and drugs Chapter I- food and drug administration department of health and human services Subchapter A- General.

Food and Drug Administration Division of Pulmonary and Allergy Drug Products Summary Comments - Orally Inhaled and Intranasal Budesonide and Fluticasone.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

1 Lotronex ® (alosetron HCl) Tablets Introduction Victor F. C. Raczkowski, M.D. Director, Division of Gastrointestinal and Coagulation Drug Products April.

CLINICAL EFFICACY Oral Telithromycin George Rochester, PhD, CCRN Statistical Reviewer Division of Biometrics III Division of Anti-infective Drug Products.

TB Alliance-Bayer Partnership Background Information.

Topic #1: EOP2A Meetings Please comment on the goals of the proposed EOP2A meeting and the impact that such meetings could have on optimizing dose selection.

Moxifloxacin Development in TB Dr. Martin Springsklee VP, Therapeutic Area Head, Clinical Development Anti-Infectives Bayer HealthCare AG GATB Annual Stakeholder.

Table 3 Clinical response success rate, according to prior effective antimicrobial therapy in hospitalized patients with community-acquired pneumonia given.

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Reasonable Assurance of Safety and Effectiveness: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division.

Introduction of New Technology: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis

Medical Device Regulatory Essentials: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Should patients with acute exacerbation of chronic bronchitis be treated with antibiotics? Advantages of the use of fluoroquinolones J. Mensa, A. Trilla

Community-acquired pneumonia in adults

Table 1. Most effective strategies to teach students to communicate the benefits and risks of medicines Strategy Considered most effective, %

Presentation transcript:

Charge to the Committee Mark Goldberger, M.D., M.P.H. Director, Office of Drug Evaluation IV CDER / FDA

Question 1 1. Based on the data presented and in your scientific and clinical opinion, do the benefits of gemifloxacin therapy outweigh the risks for the proposed indications of: (a) Community acquired pneumonia (b) Acute bacterial exacerbation of chronic bronchitis Please include as part of your discussion: the clinical and microbiologic benefits of gemifloxacin the significance of the rash, particularly as it relates to the likelihood of more severe dermatological manifestations with broader use and the likelihood of cross-sensitization to other fluoroquinolones The hepatic toxicity profile of the drug

Question 2 2. If the answer to question (1a/1b) is yes, please discuss the types of information that should be provided to physicians and patients. Please focus on the elements outlined in question 1 as well as any other issues you believe relevant. Please include as part of this discussion any caveats as to how and to whom the drug should be administered. For any risk communication/management strategy that may be appropriate, please comment on how practical and/or effective such strategies may be.

Question 3 3. If the answer to (1a/1b) is no, please recommend what additional studies or information should be obtained for (a) Community acquired pneumonia (b) Acute bacterial exacerbation of chronic bronchitis