PPT-Expanded Access Use of for Investigational Drugs in VA: Focus on COVID-19

Office of Research Protections Policy amp Education VHA Office of Research and Development Department of Veterans Affairs March 18 2020 Dial in 1 2139294232 Access Code 152743880. S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER June 2013 Clinical Medical Guidance for Industry Codevelopment of Two or More New Investigational Drugs for Use in Combination Additio 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Andrew Nicklawsky, Sarah Cusick, Zequing Lu, Anna Nordell, Jun Park, Pamela Portschy, Dongiuan Xu, Dariya Yegorova. . Compassionate Drug Use. Treatment of a seriously ill patient with a new, unapproved drug/proc. Investigational Drug Control and . Patient Safety. CUMC RP. Robert B. MacArthur, Pharm.D.. “ Why does it take so long and cost so much for me to get my study pills ? “. Topics. What, Why, and How about CUMCRP. &#x/Att;¬he; [/;ott;&#xom ];&#x/BBo;&#xx [6;.18; 21;&#x.036;&#x 96 ;6.8; ];&#x/Sub;&#xtype;&#x /Fo;&#xoter;&#x /Ty;&#xpe /;&#xPagi;&#xnati;&#xon 0;&#x/Att;¬he; Outpatient Clinical Trials. Jessica Rinaldi, CCRP. Jessica.Rinaldi@jefferson.edu. Farber Institute for Neurosciences. Learning Objectives. At the end of this activity, learners should be able to:. Understand FDA Regulations and ICH GCP Guidelines for disposition of Investigational Product in Clinical Trials. 1 King & Spalding May 22, 2014 Presentation for Clinical and Translational Science Center ─ University of California, Davis Health System EAP Request Details - To be completed Requester Contact Information (Note “NA” for items not applicable.) Name of physician or regulatory agency requestor: 2. Name of institution (if applica A drug repurposing approach for COVID-19. Md. Riad Chowdhury. 1. , . Md. . Adnan. 2,*. , . Md. Nazim Uddin . Chy. 1,*. , . A.T.M. Mostafa Kamal. 1. 1. Department of Pharmacy, International Islamic University Chittagong, . �� USA IRB Policy and Procedure��Page of may be unexpected serious adverse effects and to take appropriate measures to ensure that this is understood by the patient or the Transforming the Care of People with HIV . Rajesh T. Gandhi, MD . Massachusetts General Hospital. Harvard Medical School. Boston, Massachusetts. Financial Relationships With Commercial Entities. Dr. Gandhi has served on the scientific . Emergency use is different than. Expanded Access ("compassionate use"). Expanded Access. Serious disease, no other satisfactory alternative (may be urgent but not emergent). Research*. Requires IRB approval (or IRB chair concurrence). When They Work – When They Don’t . And Why. Steven Walker. Co-Founder, Volunteer. Abigail Alliance for Better Access . to Developmental Drugs. Kakkis. . Everylife. Foundation Panel – March 27, 2014. For VA Personnel Conducting Expanded Access Program Activities for the Treatment of Patients with Monkeypox. (May be Used in Lieu of CITI Modules for ORD-Required Training in Human Subjects Ethical Protections).