Remove 2019 Remove Clinic Remove Complication Remove Education
article thumbnail

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. Average Number of Industry Days to MDUFA IV Decision 54.69

article thumbnail

FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act

FDA Law Blog

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s But even before the House Energy and Commerce Committee acts, the Senate Health, Education, Labor and Pensions Committee held a April 26, 2022 hearing on UFA reauthorization. and more likely 15-20. and Peter Marks, M.D.,

IT 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

The Clinical Problem Solvers

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. One example that is presented involves the complicated relationship between the United States and Chinese immigrants and farmworkers in California.

article thumbnail

Episode 232: Anti-Racism in Medicine Series – Episode 15 – Housing is Health: Racism and Homelessness – Clinician + Community Perspectives

The Clinical Problem Solvers

Dr. Kushel detailed how the use of dehumanizing language equates to complicity in a narrative that systemically harms our neighbors with lived expertise in homelessness. Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. Rothstein, R. Segregated by Design. Silkworm Studio. link] Swift, C.

article thumbnail

Psychedelics – reasons for caution: Stacy Fischer, Brian Anderson, Theora Cimino

GeriPal

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Alex: It’s complicated. We, for very complicated reasons, ended up with niacin.