Search results
Results from the WOW.Com Content Network
Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. [3] In addition, clinical research may require Institutional Review Board or Research Ethics Board and possibly other ...
New Drug Application – a submission to the FDA by a pharmaceutical company for review and approval of a new drug Abbreviated New Drug Application – a submission to the FDA review and approval of a generic drug; FDA Fast Track Development Program – a designation given to an NDA by the FDA that accelerates review and approval of new drugs
Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- plasma derivatives, including immunoglobulins, hyperimmune products, and antitoxins. Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR) [2]
In a scientific research study or clinical trial, a flaw in the study design or the method of collecting or interpreting information. Biases can lead to incorrect conclusions about what the study or clinical trial showed. (NCI) When a point of view prevents impartial judgment on issues relating to the subject of that point of view.
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1]
The U.S Food and Drug Administration will give $50 million over five years to the universities. Duke and UNC receive millions to set up new FDA center. Here’s what they’ll research.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!