The FDA Wednesday published 26 new and 43 revised product-specific guidances on developing generic drugs and generating the evidence needed to support approval of abbreviated new drug applications (ANDAs). The batch of draft guidances includes 10 new and 24 revised guidances for complex products and 36 guidances for products with no approved generic. The guidances reference drugs used to treat such diseases as HIV, leukemia, opioid use disorder and post-partum depression. Comments on the draft guidances are due by Aug. 3, 2020.
The FDA updated the question-and-answer appendix in its guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” by adding a question on Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records. The update also expands on the question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes and observer-reported outcomes.
Responding to the increase in physician requests to treat patients with investigational drugs under the expanded access pathway during the COVID-19 pandemic, the FDA Tuesday published a guidance establishing procedures to guide institutional review boards (IRBs) in dealing with requests for exemption from full IRB reviews. It also discusses factors IRBs should consider when assessing benefits and risks for a particular patient being treated under expanded access.
The U.S. House Select Subcommittee on the Coronavirus Crisis wants the details of contracts between the Biomedical Advanced Research and Development Authority and private companies researching or manufacturing COVID-19 vaccines, diagnostics or therapeutics. In a letter Tuesday to Health and Human Services Secretary (HHS) Alex Azar, the subcommittee asked for the contracts or agreements; all evaluations, rankings, independent government cost estimates or other analyses of proposals for the contracts; and a detailed description of how HHS will ensure that approved coronavirus vaccines or therapeutics are affordably priced.