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2. Investigator's brochure - Wikipedia

   en.wikipedia.org/wiki/Investigator's_brochure

   Investigator's brochure. In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process ...

3. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US. The EU Commission's Directive 2005/28/EC 63 Chapter 4 states 'the trial master file shall consist of essential documents ...

4. Clinical trial - Wikipedia

   en.wikipedia.org/wiki/Clinical_trial

   A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...

5. Electronic trial master file - Wikipedia

   en.wikipedia.org/wiki/Electronic_trial_master_file

   An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

6. US FDA recommends steps to improve diversity in clinical trials

   www.aol.com/news/us-fda-recommends-steps-improve...

   (Reuters) -The U.S. Food and Drug Administration on Wednesday recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials.

7. Center for Biologics Evaluation and Research - Wikipedia

   en.wikipedia.org/wiki/Center_for_Biologics...

   The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of ...