DOCSLIB.ORG

(Ezogabine): a REMS Assessment Survey

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
(Ezogabine): a REMS Assessment Survey View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Drugs - Real World Outcomes (2015) 2:335–344 DOI 10.1007/s40801-015-0042-5 SHORT COMMUNICATION Physician and Pharmacist Understanding of the Risk of Urinary Retention with Retigabine (Ezogabine): A REMS Assessment Survey 1,2 3 4 5,6 Lianna Ishihara • Melissa Beck • Sara Travis • Olusegun Akintayo • Neil Brickel5 Published online: 7 October 2015 Ó The Author(s) 2015. This article is published with open access at Springerlink.com Abstract RTG/EZG and to evaluate the effectiveness of the com- Background The Risk Evaluation and Mitigation Strategy munication plan. (REMS) for retigabine/ezogabine (RTG/EZG) required an Methods This was a US-based, cross-sectional, non-in- evaluation of the effectiveness of the communication plan terventional, observational survey, conducted from Febru- to communicate about the risks with use of RTG/EZG. ary to April 2013, of physicians who had prescribed RTG/ Objective GlaxoSmithKline conducted a survey to assess EZG in the past year, and pharmacists who had dispensed understanding of the risk of urinary retention (UR) with an antiepileptic drug within the past 3 months. Thirteen primary objective questions (five specific to UR risk) were included in the survey, which assessed healthcare profes- sionals’ (HCPs’) understanding of UR risk and symptoms of acute UR associated with RTG/EZG. The primary out- Electronic supplementary material The online version of this article (doi:10.1007/s40801-015-0042-5) contains supplementary come was the proportion of HCPs correctly answering each material, which is available to authorized users. question. For each question, a proportion of correct responses C80 % was considered to represent sufficient & Lianna Ishihara [email protected] understanding of associated risks. Results Of 1028 HCPs screened, 373 participated. Six Melissa Beck [email protected] of 13 questions (3/5 specific to UR risk) met the C80 % Sara Travis [email protected] Olusegun Akintayo Key Points [email protected] Neil Brickel Survey results demonstrated a mixed level of [email protected] understanding of aspects of UR risk associated with 1 Department of Epidemiology, GlaxoSmithKline, Uxbridge, retigabine/ezogabine (RTG/EZG) among Middlesex, UK prescribers. 2 Present Address: Lundbeck SAS, 37–45 Quai du President Pharmacists displayed a lower level of understanding Roosevelt, 92130 Issy-les-Moulineaux, France than prescribers, probably due to the short time that 3 Regulated Healthcare Market Research, Concentrics RTG/EZG had been available for prescription. Research LLC, Indianapolis, IN, USA 4 Project Operations, Concentrics Research LLC, Indianapolis, A key insight from the survey was that the questions IN, USA should be focused on the objective to assess specific 5 risks and evaluate effectiveness of the Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, Middlesex, UK communication plan, and additional questions should not be included to avoid adding complexity. 6 Present Address: Apotex Inc., Toronto, Canada 336 L. Ishihara et al. threshold for correct responses in the physician cohort. (DEA), in line with the Controlled Substances Act, in order No questions achieved this threshold in the total phar- to determine the scheduling status. macist group; however, four questions scored C80 % As a condition of approval, the FDA required that GSK when stratified by pharmacists who had dispensed RTG/ assess this communication plan’s effectiveness. Accord- EZG. ingly, a survey was conducted among a sample of HCPs to Conclusions Results demonstrated a mixed level of evaluate knowledge of UR risk with RTG/EZG [10]. The understanding of aspects of UR risk associated with RTG/ survey focused on the risks described in the DHCP letter EZG, although some risk questions did not meet the 80 % for RTG/EZG, and assessed where HCPs prefer to seek threshold, especially among pharmacists. This is likely to information for RTG/EZG (e.g., DHCP letters, website, have been due to the short time that RTG/EZG has been product labeling). Here we report the results of this survey. available and its limited use. This study provides the first evaluation of the REMS communication plan on the risk of UR with RTG/EZG. 2 Methods 1 Introduction 2.1 Study Design Retigabine (RTG; international nonproprietary name)/ This was a cross-sectional, non-interventional, observa- ezogabine (EZG; US adopted name) is an antiepileptic tional survey of HCPs who prescribe RTG/EZG or dis- drug (AED) approved in the US (as POTIGATM, pense AEDs. The study did not include intervention; GlaxoSmithKline [GSK] and Valeant) for the adjunctive therefore, institutional review board approval was not treatment of partial-onset seizures in adults who have deemed necessary. responded inadequately to several treatments and for whom the benefits outweigh the risk of retinal abnor- 2.2 Sampling and Study Population malities and potential decline in visual acuity [1]. In clinical studies investigating the efficacy and safety of From a Concentrics Research market research partner’s RTG/EZG, an increased risk of urinary retention (UR) custom database of more than 668,000 geographically and was reported in patients receiving RTG/EZG compared therapeutically diverse US HCPs, approximately 14,000 with placebo [2–6]. eligible physicians and pharmacists were contacted from a RTG/EZG was approved in June 2011 with a US Food demographically representative population who prescribe and Drug Administration (FDA) requirement for a Risk RTG/EZG (neurologists, neurosurgeons, epileptologists), Evaluation and Mitigation Strategy (REMS) [7]. According or dispense AEDs (pharmacists). The original mailing list to the FDA Amendments Act of 2007, the FDA may require for the DHCP letter included prescribers, emergency room a drug manufacturer to submit a REMS, which is intended physicians and urologists, the HCPs most likely to come to manage known or potential serious risks associated with a into contact with RTG/EZG-treated patients who may have drug and to ensure that the benefits of the drug outweigh the UR symptoms. This survey focused only on recruiting risks [8, 9]. The REMS for RTG/EZG consisted of a com- potential prescribers and the overlap between the DHCP munication plan for healthcare professionals (HCPs), mailing list and the Concentrics database is not known. including prescribing physicians and dispensing pharma- cists, designed to disseminate information on the risk of UR 2.3 Survey Inclusion, Exclusion, and Withdrawal with RTG/EZG and highlight the importance of advising Criteria patients to seek immediate attention for symptoms of UR, including inability to urinate and/or pain with urination. The Inclusion criteria included practicing physicians who had communication plan had two elements: (i) a Dear Health- prescribed RTG/EZG within the past year, and practicing care Professional (DHCP) letter, disseminated within pharmacists who had filled a prescription for at least one 4 weeks of first retail availability (May 7, 2012) and AED within the past 3 months. Physicians and pharmacists annually for the following 2 years; and (ii) a REMS pro- currently employed by, or who were representatives of, a gram website available at the time of launch (April 16, pharmaceutical company or manufacturer of medicines or 2012; no longer active). The delay between the approval of healthcare products, or who were contributors to, or editors the new drug application (NDA; June, 2011) and retail of, published guideline committees for epilepsy or UR, were availability was caused by the requirement for RTG/EZG to ineligible. Additionally, HCPs who previously participated be reviewed by the US Drug Enforcement Administration in the pilot REMS study for RTG/EZG, or who were Understanding of Retigabine Urinary Retention Risk 337 employees of GSK or Concentrics Research, were excluded. 3.2 Demographics and Baseline Characteristics HCPs could withdraw from the study at any time. Physicians reported that their primary specialty was neu- 2.4 Screening and Baseline Assessments rology (64 %) or epileptology (36 %). Pharmacists repor- ted community/retail (55 %) or hospital/clinic (45 %) as HCPs were contacted initially by telephone, email, or fax their primary specialty. Most HCPs had been practicing with an invitation to participate in the study, conducted medicine/pharmacy and prescribing/dispensing AEDs for from February through April 2013. A standardized 5–35 years. screening questionnaire conducted by telephone assessed Prescribing physicians treated patients across all ages, eligibility, demographics, and interest in study participa- and most reported a total number of more than 1000 tion. After recruitment, HCPs’ understanding of the patients, more than 100 of whom had epilepsy. Sixty per- symptoms and risks of UR with RTG/EZG was evaluated cent of physicians had prescribed, and 41 % of pharmacists by means of an online survey or telephone interview. had filled prescriptions for AEDs to more than 50 patients Thirty closed-ended questions were asked to assess the monthly during the past year. Most pharmacists had not following: demographics and prescribing/dispensing his- dispensed (77 %) RTG/EZG or answered (83 %) patients’ tory of each HCP; understanding of RTG/EZG key safety questions about RTG/EZG in the past year. Of those who messages based on US prescribing information and prac- had done so, 44 % reported
Load more

Recommended publications
  • CRPT-113Hrpt565-Pt2.Pdf
    113TH CONGRESS REPT. 113–565 " ! 2d Session HOUSE OF REPRESENTATIVES Part 2 IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT SEPTEMBER 19, 2014.—Committed to the Committee of the Whole House on the State of the Union and ordered to be printed Mr. GOODLATTE, from the Committee on the Judiciary, submitted the following R E P O R T [To accompany H.R. 4299] [Including cost estimate of the Congressional Budget Office] The Committee on the Judiciary, to whom was referred the bill (H.R. 4299) to amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufac- turers and distributors seeking to conduct clinical testing, having considered the same, report favorably thereon with an amendment and recommend that the bill as amended do pass. CONTENTS Page The Amendment ...................................................................................................... 1 Purpose and Summary ............................................................................................ 2 Background and Need for the Legislation ............................................................. 2 Hearings ................................................................................................................... 3 Committee Consideration ........................................................................................ 3 Committee Votes .....................................................................................................
    [Show full text]
  • Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
    Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions on the content of the draft document contact (CDER) Min Chen, 301-827- 3169 (phone); 301-827-5190 (fax), or (CBER) Miles Braun, 301-827-3974 (phone); 301- 827-3529 (fax). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2001 G:\4177dft.doc Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Additional copies are available from: Drug Information Branch (HFD-210) Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4570 Internet at http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448 (Fax) 1-888-CBERFAX or 301-827-3844 (Voice Information) 1-800-835-4709 or 301-827-1800 Internet at http://www.fda.gov/cber/guidelines.htm U.S.
    [Show full text]
  • Guidance for Industry
    Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) November 2020 User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: [email protected] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: [email protected] https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics- guidances U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) November 2020 User Fees Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION............................................................................................................
    [Show full text]
  • Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health
    MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4200.3 Rev. 1 POLICY AND PROCEDURES OFFICE OF THE CENTER DIRECTOR Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health Table of Contents PURPOSE ..............................................................................1 BACKGROUND ...................................................................1 POLICY .................................................................................2 PROCEDURES .....................................................................4 REFERENCES ......................................................................6 DEFINITIONS ......................................................................6 CHANGE CONTROL TABLE ............................................8 PURPOSE This MAPP establishes responsibilities and procedures in the Center for Drug Evaluation and Research (CDER) for consulting the Controlled Substance Staff (CSS) regarding the evaluation of drug abuse potential and labeling, drug scheduling, dependence liability, and drug abuse risks to the public health. This MAPP also provides a description of the role of CSS in the drug abuse assessment and the drug scheduling process within CDER. BACKGROUND CSS provides expertise to the Food and Drug Administration (FDA) Centers and CDER Offices and Divisions as part of the review process in assessing drugs for abuse potential and dependence liability. CSS fulfills
    [Show full text]
  • Prandin (Repaglinide) Tablets
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 020741/S-044 SUPPLEMENT APPROVAL Clinipace, Inc. Agent for Gemini Laboratories, LLC Attention: Catherine Kessler Vice President 4840 Pearl E Cir, Ste 201E Boulder, CO 80301 Dear Ms. Kessler: Please refer to your Supplemental New Drug Application (sNDA) dated and received June 29, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Prandin (repaglinide) tablets. This Prior Approval supplemental new drug application provides for revisions to the prescribing information (PI) to conform to the Pregnancy and Lactation Labeling Rule (PLLR). APPROVAL & LABELING We have completed our review of this supplemental application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text with the minor editorial revisions, listed below, and reflected in the enclosed labeling. • In the HIGHLIGHTS OF PRESCRIBING INFORMATION, the date has been revised to 1/2019. • The footer on all pages has been deleted. WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of Prescribing Information. This waiver applies to all future supplements containing revised labeling unless we notify you otherwise. Reference ID: 4378916 NDA 020741/S-044 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
    [Show full text]
  • Download FDA's Expedited Drug Approval Programs
    Expedited Drug Approval Programs The process for collecting evidence in support of a new drug approval involves multiple steps. Drug developers (sponsors) collect evidence during pre-clinical and clinical phases of the process and submit it to the U.S. Food and Drug Administration (FDA) for evaluation of the drug’s safety and efficacy. The next step is a final review for marketing authorization which occurs when a drug sponsor submits a New Drug Application (NDA) to FDA for small molecule drugs or a Biologics Licensing Application (BLA) for biologics. FDA follows a standard review process – which typically takes up to 10 months – to determine whether to approve the drug. Throughout this process, from drug development to post- market monitoring, there are various points in which drug sponsors and FDA interact and exchange information. The time it takes for drug development and approval varies by drug and therapeutic area and FDA review is only part of this process. In most cases, most of this time is spent by drug sponsors in the data collection phases, e.g. clinical trials. But not all approvals follow the standard review process. Drug therapies that address unmet medical needs, treat serious or life-threatening conditions, or show a significant advantage over current therapies may be eligible for one or more of FDA’s four Expedited Review Programs. These programs are designed to accelerate the approval process and make the therapies available to patients quicker if it is determined the therapies’ benefits justify their risks.1 The four Expedited Review Programs are Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy.
    [Show full text]
  • FDA Fast Track and Priority Review Programs
    FDA Fast Track and Priority Review Programs February 21, 2008 Congressional Research Service https://crsreports.congress.gov RS22814 FDA Fast Track and Priority Review Programs Summary By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is relevant in fewer situations than the others. The Fast Track program encourages a sponsor to consult with FDA while developing a product. Unlike the others, Priority Review involves no discussions of study design or procedure; it relates only to an application’s place in the review queue. Analysis of total approval time for approved applications under the Fast Track and Priority Review programs shows that for seven of the past nine years, Fast Track products have shorter median approval times than do all those applications assigned to Priority Review. Congressional Research Service FDA Fast Track and Priority Review Programs Contents Mechanisms to Expedite the Development and Review Process .................................................... 1 Accelerated Approval ...............................................................................................................
    [Show full text]
  • Public Assessment Report
    20 January 2011 EMA/407212/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Trobalt International Nonproprietary Name: retigabine Procedure No. EMEA/H/C/001245 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Medicinal product no longer authorised 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 5 1.1. Submission of the dossier .................................................................................... 5 Information on Paediatric requirements ....................................................................... 5 Information relating to orphan market exclusivity .......................................................... 5 Scientific Advice ....................................................................................................... 5 Licensing status ....................................................................................................... 6 1.2. Steps taken for the assessment of the product ....................................................... 6 2. Scientific discussion ................................................................................ 7
    [Show full text]
  • 022345Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022345Orig1s000 OTHER REVIEW(S) SEALD LABELING: PI SIGN-OFF REVIEW APPLICATION NUMBER NDA 022345 APPLICANT Valeant Pharm N.A. PRODUCT NAME Potiga (ezogabine) SUBMISSION DATE 15 April 2011 PDUFA DATE 15 June 2011 SEALD SIGN-OFF DATE 10 June 2011 OND ASSOCIATE DIRECTOR Laurie Burke FOR STUDY ENDPOINTS AND LABELING This memo confirms that no critical prescribing information (PI) deficiencies were noted in the SEALD Labeling Review filed 8 June 2011 and no critical deficiencies have been found in the final agreed-upon PI reviewed today. SEALD has no objection to PI approval at this time. Reference ID: 2959126 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- LAURIE B BURKE 06/10/2011 Reference ID: 2959126 NDA 22345 Potiga Potiga PMR/PMC Development Template: PREA Efficacy/Safety Study for Ezogabine PMR # 1 This template should be completed by the PMR/PMC Development Coordinator and included for each PMR/PMC in the Action Package. PMR/PMC Description: Prospective, randomized, placebo-control, double-blinded efficacy/ safety trial of Potiga (ezogabine) in children >12 years old. PMR/PMC Schedule Milestones: Final protocol Submission Date: 11/2012 Study/Clinical trial Completion Date: 01/2018 Final Report Submission Date: 05/2018 Other: MM/DD/YYYY 1. During application review, explain why this issue is appropriate for a PMR/PMC instead of a pre-approval requirement. Check type below and describe. Unmet need Life-threatening condition Long-term data needed Only feasible to conduct post-approval Prior clinical experience indicates safety Small subpopulation affected Theoretical concern Other This is part of a PREA requirement.
    [Show full text]
  • Elagolix for Treating Endometriosis
    Elagolix for Treating Endometriosis Evidence Report June 15, 2018 Prepared for ©Institute for Clinical and Economic Review, 2018 ICER Staff/Consultants University of Colorado Skaggs School of Pharmacy Modeling Group* Steven J. Atlas, MD, MPH R. Brett McQueen, PhD Director, Primary Care Research and Quality Assistant Professor Improvement Network Department of Clinical Pharmacy Massachusetts General Hospital Center for Pharmaceutical Outcomes Research Geri Cramer, BSN, MBA Jonathan D. Campbell, PhD Research Lead, Evidence Synthesis Associate Professor Institute for Clinical and Economic Review Department of Clinical Pharmacy Center for Pharmaceutical Outcomes Research Patricia G. Synnott, MALD, MS Senior Research Lead, Evidence Synthesis Melanie D. Whittington, PhD Institute for Clinical and Economic Review Research Instructor Department of Clinical Pharmacy Varun Kumar, MBBS, MPH, MSc Health Economist Samuel McGuffin Institute for Clinical and Economic Review Professional Research Assistant Department of Clinical Pharmacy Celia Segel, MPP Program Manager Institute for Clinical and Economic Review Daniel A. Ollendorf, PhD Chief Scientific Officer *The role of the University of Colorado Skaggs Institute for Clinical and Economic Review School of Pharmacy Modeling Group is limited to the development of the cost-effectiveness Steven D. Pearson, MD, MSc model, and the resulting ICER reports do not President necessarily represent the views of CU. Institute for Clinical and Economic Review DATE OF PUBLICATION: June 15, 2018 Steven Atlas served as the lead author for the report. Geri Cramer and Patricia Synnott led the systematic review and authorship of the comparative clinical effectiveness section. Varun Kumar was responsible for oversight of the cost-effectiveness analyses and developed the budget impact model.
    [Show full text]
  • Investigational New Drug Applications
    Academic Entrepreneurship for Medical and Health Scientists Volume 1 Issue 3 Intellectual Property-Regulatory Article 7 9-26-2019 FDA Drug Regulation: Investigational New Drug Applications Bike Su Oner Clinical Cell and Vaccine Production Facility, University of Pennsylvania Sergio R. Labra Department of Chemistry, The Scripps Research Institute Shelly Fehr University of Pennsylvania Follow this and additional works at: https://repository.upenn.edu/ace Part of the Entrepreneurial and Small Business Operations Commons Recommended Citation Oner, Bike Su; Labra, Sergio R.; and Fehr, Shelly (2019) "FDA Drug Regulation: Investigational New Drug Applications," Academic Entrepreneurship for Medical and Health Scientists: Vol. 1 : Iss. 3 , Article 7. Available at: https://repository.upenn.edu/ace/vol1/iss3/7 This paper is posted at ScholarlyCommons. https://repository.upenn.edu/ace/vol1/iss3/7 For more information, please contact [email protected]. The Academic Entrepreneurship for Medical and Health Scientists book project is free to all – we don’t ask for money but we truly value your feedback. Below are two links -- one to a brief feedback survey and the other to a place where you can sign up to join our community of innovators and problem solvers. You can visit them and give tell us what you think now OR after you've had the chance to read this chapter -- either one works for us! Please complete our brief feedback survey https://redcap.chop.edu/surveys/?s=HDXK3CE48L Join our growing community of Academic Entrepreneurs! https://bit.ly/3bnWTuD FDA Drug Regulation: Investigational New Drug Applications Summary • The Food and Drug Administration (FDA)’s primary objective is to ensure safety.
    [Show full text]
  • Commonly Used Abbreviations and Terms in Clinical Trials
    COMMONLY USED ABBREVIATIONS AND TERMS in CLINCAL TRIALS Abbreviation Definition ADR Adverse Drug Reaction AE Adverse Event AUC Area Under the Curve BLA Biologic Licensing Application BUN Blood Urea Nitrogen CAP College of American Pathologists CBER Center for Biologics Evaluation and Research (FDA) CDER Center for Drug Evaluation and Research (FDA) CDRH Center for Devices and Radiological Health (FDA) CFR Code of Federal Regulations CI Confidence Interval CLIA Clinical Laboratory Improvements Amendments Cmax Maximum Plasma Concentration Cmin Minimum Plasma Concentration CNT Consented but Not Treated Cr Serum Creatinine CRA Clinical Research Associate CRC Clinical Research Coordinator CRF Case Report Form CRO Contract Research Organization CT Computed Tomography CTA Clinical Trials Agreement CTC Circulating Tumor Cell Count CTCAE Common Terminology Criteria for Adverse Events CYP Cytochrome P450 DAR Drug or Device Accountability Records DHEA Dihydroepiandrosterone DLT Dose Limiting Toxicity DNA Deoxyribonucleic Acid DSMB Data Safety Monitoring Board DSMP Data Safety Monitoring Plan EC Ethics Committee ECG Electrocardiogram ECOG Eastern Cooperative Oncology Group (Used to determine Performance Status ) EDC Electronic Data Capture EMEA European Agency for the Evaluation of Medicinal Products FDA Food and Drug Administration FWA number Federal Wide Assurance number (number assigned to IRB ) GCP Good Clinical Practices GLP Good Laboratory Practices GMP Good Manufacturing Practices HAQ Health Assessment Questionnaire HDE Humanitarian Device
    [Show full text]