'Drug evaluation' presentation slideshows

A History of Stats at the FDA

A History of Stats at the FDA. Mary A. Foulkes, Ph.D. U.S. Food And Drug Administration Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research. 2006 FDA/Industry Statistics Workshop.

697 views • 52 slides

SLIDES FOR NDA 21-213 ADVISORY COMMITTEE PRESENTATION

SLIDES FOR NDA 21-213 ADVISORY COMMITTEE PRESENTATION. Joint Advisory Committee Meeting FDA Presentations. Clinical Efficacy and Safety Review Mary H. Parks, MD (DMEDP) Review of Actual-Use Trials Andrea Leonard-Segal, MD (DOTCDP) Drug-Drug and Drug-Food Interactions Jim Wei, PhD (OCPB)

714 views • 48 slides

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528 views • 37 slides

Chelation Therapy

642 views • 32 slides

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO. PADE Inspectional Program. Headquarters scientists use adverse event reports to evaluate the safety of marketed drugs

421 views • 31 slides

Drug Recognition Expert

Drug Recognition Expert. 7-Day School. Session 1. 110 Minutes. Introduction and Overview. Housekeeping. Paperwork Mandatory attendance Breaks Facility Interruptions All electronic devices off. Drug Recognition Expert (DRE) Certification Phases. DRE Pre-School. DRE 7-Day School.

404 views • 29 slides

Requirements for Standardized Study Data: Update on Guidance

Requirements for Standardized Study Data: Update on Guidance. Ron Fitzmartin, PhD, MBA Data Standards Program Office of Strategic Programs Center for Drug Evaluation & Research Food and Drug Administration. Presented at the CSS / PhUSE Meeting Silver Spring, MD 17 March 2014.

413 views • 27 slides

Session 1

Session 1. 35 Minutes. Introduction: Preliminary Training for Drug Evaluation and Classification Program. Administrative Matters. Housekeeping. Paperwork Mandatory attendance Breaks Facility Interruptions All electronic devices off. 1- 2. Participant Introductions. Name Agency

243 views • 24 slides

Regulatory Concepts for Dual Indication Combination Products

Regulatory Concepts for Dual Indication Combination Products. Charu Mullick, M.D. Division of Antiviral Products, CDER U.S. Food and Drug Administration Multipurpose Prevention Technologies Satellite AIDS 2012, Washington D.C. FDA Disclaimer.

319 views • 18 slides

InnoVation Exploration Team (IVET)

InnoVation Exploration Team (IVET). Generic Animal Drug Alliance April 21, 2011. New Model for Success. Our old business model for animal drug evaluation is not sufficient. ONADE is tasked with new challenges and opportunities beyond drug evaluation

372 views • 15 slides

Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD

Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD. Introductory Remarks. Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research. Accomplishments of Committee in the Last Three Years.

216 views • 14 slides

Pediatrics Update

Pediatrics Update. Dianne Murphy, M.D. Director, Office of Pediatric Therapeutics Office of the Commissioner Director, OCTAP Center for Drug Evaluation March 3, 2003. Pediatrics Update. Organization of Pediatrics - D. Murphy New Office of Pediatric Therapeutics - D. Murphy

397 views • 13 slides

FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008

FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008. Introduction and Update Helen N. Winkle Director, Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration. Welcome.

348 views • 9 slides

Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D.

Bridging Study Evaluation - The Three-year Experience in Taiwan Center for Drug Evaluation Yi-jin Chiou, Ph.D. October 28, 2003. Regulatory Reform in Clinical Trials.

462 views • 7 slides

Alcohol and Drug Evaluation Atlanta GA

Alcohol and Drug Evaluations are confidentially administered on an outpatient basis and assess addictive behaviors for a variety of substances, including methamphetamines, cocaine, heroin, marijuana, alcohol, and several others.

111 views • 7 slides

Electronic cigarettes

Electronic cigarettes. B attery-powered devices that often look like cigarettes but do not contain tobacco. C ontain an airflow sensor and a heating element. Some can be recharged via a USB port. Others are disposable

220 views • 6 slides

Alliance for a Stronger FDA

Alliance for a Stronger FDA. July 10, 2014. Center for Drug Evaluation and Research (CDER). CONFIDENTIAL. CDER Sentinel Funding FY 2008- FY 2013. FY 2013 includes a reduction in BA due to sequestration.

173 views • 5 slides

Alcohol and Drug Evaluation in Marietta, Atlanta and Decatur

American Alternative Court Services give court affirmed alcohol and drug evaluations for infringement including DUI, rash driving; ownership of drugs; underage utilization; and tumultuous lead; and in addition cases including abusive domestic behavior at Atlanta, Decatur and Marietta centers. Our assessment procedure includes assessment tools and individual meeting for assessing emotional security. The mission of AACS is to alleviate individuals from their aggravating anger. Feel free to get in touch with us today

22 views • 2 slides

E. coli, H. pylori, P. aeruginosa , P. gingivalis , Staphylococcus spp.

269 views • 1 slides

Alcohol and Drug Evaluation

The Alcohol and Drug Evaluation is usually court mandated and ordered by the judge as a term & condition for the successful completion of a probationary period, also, ordered by a judge or court system. Alcohol and Drug Evaluation is to use all the information provided in the beginning, middle, and end of the evaluation in combination with a patientu2019s criminal background and history to provide the best options needed to provide proper treatment. To know more about any treatment Please call our office at 404-594-1770 to book an expedited appointment today.

28 views • 1 slides