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Green Practice News: May 2025

My Green Doctor

For instance, the UK government’s initiative to install solar panels on National Health Service sites is projected to save each site up to £45,000 annually, amounting to approximately £13 million in total savings per year. The breadth of services provided by modern day medicine is profound.

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FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. The regulatory uncertainty has ill?befitted Part 807, Subpart E). FDCA § 513(f)(5). 515(d)(2)(C).

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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

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Biased research, aggressive sales, harmful drugs

The Health Policy Exchange

Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Unfortunately, recent case studies have illustrated that FDA approval does not necessarily provide assurances of effectiveness and safety. Approval from the U.S. Could the FDA and other U.S.

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New Administration, “Old” Rules: FDA and HHS Jointly Withdraw 11th Hour Trump Administration Proposal for Sweeping 510(k) Exemption

FDA Law

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. When this author read the January Notice, it seemed like an ill-thought-out proposal. The comment period closes May 17, 2021.

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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.