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Green Practice News: April 2025

My Green Doctor

from 2000 to 2018 among people over 65 years old. It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. Encourage Small Changes That Add Up Shift your clinic toward paperless records and LED lighting to reduce waste and energy costs.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Pfizer emphasized to OIG that it would not offer this copay assistance as part of any advertisement or solicitation for tafamidis.

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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. By David B. Clissold & Sara W.

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DOJ Re-Brands Guidance Documents

FDA Law Blog

The federal government does its own version of rebranding with each change in administration. This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g.,

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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

Medical 98
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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

Medical 75
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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.