TAG ARCHIVES FOR FDA

14
Jul2017

This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive government study is working on community engagement efforts, the Food and Drug Administration (FDA)’s plan for new patient-focused drug development guidance, and a European Union committee’s opinion that nonhuman primate research should continue in its member countries. Read more

23
May2017

PRIM&R has long prided itself on its role as a convener of divergent opinions and viewpoints. One of the ways we fulfill this role is through the development and nurturing of a diverse membership community, hailing from all parts of the research enterprise, from institutions large and small, public and private, from across the country and around the world. Read more

21
Apr2017

This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market. Read more

14
Apr2017

This month’s question places you in the FDA commissioner’s seat: You are the Commissioner of the FDA. A friend has informed you of the following situation: Over 1,000 people with severe, refractive emphysema have banded together to test a drug that is approved for asthma but not emphysema. Participants “drew straws” to determine which of them would ask their physicians for a prescription. While the FDA has no authority over the practice of medicine, it does have authority over clinical studies that create generalizable knowledge. Read more

5
Apr2017

In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and [...] Read more

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