FDA Law

SEPTEMBER 21, 2022

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). On the same day, September 7, CDRH published a policy for monkeypox tests. We note that this policy defines an “experienced developer” more narrowly than the COVID-19 policy.

Manufacturing 52

Manufacturing Diagnose Diagnosis IT 52

Common Sense Family Doctor

FEBRUARY 15, 2025

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The ad states that patients may pay as little as $5 per dose, 4 times per year.… Who could blame a patient for believing the drug doesn’t cost much.

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Family Physician Manufacturing Families Family 40

FDA Law

SEPTEMBER 28, 2022

Approximately six months before the patient’s surgery, the FDA issued a Safety Communication discouraging the use of power morcellation due to the risk that the procedure could spread cancerous tissue in patients with undiagnosed uterine sarcoma. The New Jersey Punitive Damages Act (PDA) provides that “punitive damages may be awarded.

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Provider Hospital Patients Manufacturing 59