Articles Tagged With: FDA
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FDA Issues Emergency Use Authorization for Bamlanivimab
While the search for a vaccine continues, the agency adds to the list of stop-gap therapeutics to battle COVID-19.
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FDA Answers Audit Questions from Researchers, Industry
The Food and Drug Administration issued new guidance on inspections during the COVID-19 pandemic, as the agency began to resume domestic inspections in July.
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FDA: Barrier Enclosures for Aerosol-Generating Procedures May Increase Risk to HCPs
Citing increased risk to healthcare workers and patients, the Food and Drug Administration has revoked emergency use authorization for barrier enclosure devices that cover a COVID-19 patient’s head and upper body during aerosol‐generating procedures such as tracheal intubation.
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Vaccine Trials Should Follow the Four Ethical Principles
All human research, including COVID-19 vaccine trials, should be guided by the four ethical principles of autonomy, beneficence, nonmaleficence, and justice. When researchers, data safety monitoring boards, or the Food and Drug Administration decide to stop a clinical trial or expedite approval or use of an investigational product, these principles still apply.
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Confusion, Skepticism Abound Regarding Convalescent Plasma as a COVID-19 Therapeutic
From collection to analysis to reporting, it seems everyone registered a complaint about the entire process.
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FDA Releases Q&A for COVID-19 and Clinical Trials
The Food and Drug Administration recently released updated guidance on conducting clinical trials of medical products during the COVID-19 pandemic. The new version of the guidelines includes a question-and-answer section that clarifies some emergency changes affecting human research protection policies and procedures.
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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FDA: Do Not Use Antibody Tests to Diagnose COVID-19
While antibody tests are broadly seen as a way to determine immunity and exposure to the pandemic coronavirus, the Food and Drug Administration recently warned that tests should not be used as the “sole basis to diagnose COVID-19.”
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FDA Guidance Offers Foundation for IRB, Researcher Flexibility
The Food and Drug Administration’s guidance on conducting clinical trials during the pandemic provides reassurance that IRBs and research organizations can employ flexibility as they make changes to accommodate a world in which many patient visits are conducted remotely. The guidance does not change or modify existing regulations, but synthesizes existing regulations and emphasizes the built-in flexibility.
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Federal Agencies, Pharma Industry Work to Speed COVID-19 Therapeutics, Vaccine
Public-private partnership aims to streamline, coordinate large-scale efforts.