by admin | Dec 7, 2020 | News
Christine P. Bump to Speak at FDLI Enforcement Conference Penn Avenue Law’s Christine P. Bump will be participating in the panel, “Digital Health: Enforcement, Regulations, and Risks,” as part of the Food and Drug Law Institute’s virtual Enforcement, Litigation, and...
by admin | Aug 24, 2020 | News
FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority On August 19, 2020, HHS settled a debate that began nearly 30 years ago: FDA cannot regulate laboratory developed tests (LDTs) until and unless the agency...
by admin | Jul 15, 2020 | News
Opportunity for Stakeholders to Impact FDA’s “Non-Device” Software Report There is still time for stakeholders to impact FDA’s 2020 update to its congressionally mandated report on best practices for “non-device” software, i.e., software functions excluded from the...
by admin | Jul 4, 2020 | News
Penn Avenue Law & Policy Evaluates COVID-19 Tests for Healthcare Client COVID-19 testing is a rapidly evolving domain. Millions of concerned individuals are seeking COVID-19 tests. Meanwhile, testing healthcare providers continues to be essential, and...
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