![]() ![]() For drugs or biological products already marketed for different indications, previously observed or anticipated toxicities of the product were not adequately addressed by the proposed safety assessments in a clinical protocol. ![]() For example, serious pre-clinical safety signals of a drug’s toxic effect were found in animal studies at a level that patients in the trial might be exposed to.For a new drug or biological product, data from animal studies failed to support the safety of the product’s anticipated exposure (dose, route of administration, and duration) in humans for the proposed clinical trial. ![]() Some examples of safety concerns identified by FDA in COVID-19 therapy proposals include: FDA has evaluated numerous IND applications for COVID-19 therapies and in some cases, due to patient safety concerns, issued a clinical hold to prevent a trial from proceeding.įDA has been careful to assess whether proposed COVID-19 therapies in research proposals have potential safety concerns that might exacerbate the most serious and life-threatening symptoms of COVID-19 patients, such as respiratory adverse effects or pro-inflammatory immune response. More information is available on CDER’s IND Application Procedures: Clinical Hold webpage. This is to assure that subjects are not exposed to an unreasonable and significant risk of illness or injury. Once a sponsor submits an IND application, FDA may determine that sufficient information has been provided to allow the trial to proceed (issuing a “Safe to Proceed” letter), or, if there is insufficient support to assure patient safety, or if there are safety concerns, FDA can issue a “clinical hold” to prevent a proposed trial from starting. As part of its review, FDA identifies any safety concerns that the sponsor must adequately address in the IND application before proceeding with a clinical trial. More information is available on the Coronavirus Treatment Acceleration Program (CTAP) webpage. FDA has evaluated and responded to hundreds of these study proposals and questions from sponsors through this process. Many sponsors are providing clinical trial proposals to FDA for COVID-19 therapies before submitting an IND application. FDA’s Role in Reviewing Research Proposals for Patient SafetyįDA has a critical role in ensuring the safety of patients in clinical trials studying drugs or biological products for the prevention or treatment of COVID-19 that require an investigational new drug (IND) application. ![]()
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