Best Practices For Medical Device Firms Preparing for and Responding to an FDA Audit

October 10, 2022

As a manufacturer of an FDA-registered Class II or Class III medical device, the FDA may conduct an inspection of your organization at any time. In other words, your company is subject to random, unscheduled inspections. Reasons for an inspection may include a routinely scheduled investigation, an accumulation of incident reports or consumer complaints, or […]

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Can California Disrupt the Insulin Market?

November 16, 2022

California’s 2022 – 2023 budget allocates slightly more than $100 million to establish the CalRx Biosimilar Initiative – where California will develop, in partnership with a contract manufacturer, biosimilar insulin products and sell them at very reasonable prices. California intends to be selling insulin products, at a massive scale, within a few short years. 37 […]

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$30 Insulin Coming to California!

April 5, 2023

  CHANGES COMING TO THE INSULIN MARKET! Branded as “$30 Insulin by CalRx,” Governor Newsom announced on March 18, 2023, that California has entered into a $50 million, ten-year contract with Civica Rx for it to manufacture and distribute generic insulin in California. While Civica still needs to obtain FDA approval for its proposed insulin […]

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California Moves to Regulate Private Equity involvement in the Management of Physician Practice Groups

May 13, 2024

  The California legislature is debating proposed legislation (Assembly Bill 3129) that would significantly increase the California Attorney General’s powers to review and, in some circumstances, prevent private equity groups and hedge funds from investing in California hospitals, physician practices and the like. In order to become law, AB 3129 must secure approval in both […]

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