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Tag: Clinical Trials

FDA OMHHE releases new video on medical device clinical trials

FDA’s Office of Minority Health and Health Equity released a new video about the importance of diverse participation in clinical research for medical devices. The FDA not only reviews new drugs, but the agency also reviews many medical devices before they are marketed to determine if they meet FDA’s safety and effectiveness standards. Diverse participation in clinical […]

New FDA Guidance for Cancer Clinical Trial Eligibility Criteria

New FDA guidances provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. They include the following: Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections – This guidance is one in a series of guidances that […]

Recently Posted FDA [DRAFT] Guidance Document: Inclusion of Older Adults in Cancer Clinical Trials

3/6/2020 – Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer.  For the purpose of this guidance, older adults are those aged 65 years and older.  Specifically, this guidance includes recommendations for […]

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