Concierge Choice Physicians
JANUARY 28, 2025
The physician continues to accept insurance and government programs, as before. They receive enhanced support and service from staff members, and medical advocacy and coordination with other health providers the patient may see. The patient decides what’s right for them.
FDA Law
FEBRUARY 18, 2025
The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?
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Physician's Weekly
JUNE 17, 2025
Tianeptine is sold in a number of countries as a government-approved treatment for depression. But the FDA has never approved it for any medical condition in the U.S. Calello explained that it falls under a gray area of consumer supplements or products that are not regulated or tested the same way a medication would be.
FDA Law
JANUARY 18, 2022
Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).
My Green Doctor
APRIL 4, 2025
New Research: Teaching Patients about Climate Resilience Newly published original research co-authored by My Green Doctor’s Dr. Todd Sack concludes that, “ the medical office waiting room appears to be an accepted, time-efficient, and effective site to communicate knowledge on climate change and health. ” Contact us today! of total U.S.
FDA Law
JANUARY 18, 2022
Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).
FDA Law
AUGUST 4, 2022
In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”
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