Fdma Phase 4

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I am working in a very small biotech company and responsible person to submit our product related document to the FDA. We just got a letter from FDA that our product is approved and we have to signed postmarketing commitment (Phase IV Trial). I am going to discuss this matter with my boss. It is a signed commitments with FDA given by a sponsor before or after product approved by FDA to gather additional information about a product 's safety, efficacy, or optimal use.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Food, Drug and Cosmetic Act signed into law on November 21, 1997 by adding a new section 506B (21 U.S.C. 356b). FDA issued a draft guidance related to this rule in April 2001. This section provides
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Research in phase IV trial is a non-interventional study (NIS) designed to assess a treatment’s safety, tolerability, and effectiveness in a particular population in clinical practice. A sponsoring pharmaceutical company is finding new markets, to examine possible interactions with other drugs, or to determine outcomes with particular patient populations, such as pregnant women, the elderly, or those with rare disease, long-term adverse effects, and involve much larger subject populations than those traditionally involved in Phase I–III studies. “Essential to Phase IV research is the focus on how drugs work in the real world”.
In 2007, a report initiated by the Department of Health and Human Services Office of Inspector General criticized the U.S. Food and Drug Administration’s lack of oversight of postmarketing or phase 4 clinical trials because the agency did not have an effective system or a
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With variations in the types of trials, study locations, different patient or trial protocol requirements, and study durations, Phase IV studies’ total budgets range from $100,000 to tens of millions of dollars. The study also found that European Phase IV trials cost less, on average, than in the United States. According to the data, the average per-patient cost in Europe is $2,992.
The Pharmaceutical Research and Manufacturers of America reports that 11 % research and development budget is allotted to phase 4 researches. So why would manufacturers think twice about postponing required phase 4 trials? Demand for real-life outcomes, growing anxiety over the safety of existing drugs, and a changing regulatory environment all play a role. Payer groups increasingly demand data on health economics, patient-reported outcomes, reimbursement, and patient safety — information that can be derived only from postmarketing studies. Manufacturers that provide this information may ultimately differentiate their product from others and boost

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