Best Practices For Medical Device Firms Preparing for and Responding to an FDA Audit
October 10, 2022As 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 […]
Read MoreCan California Disrupt the Insulin Market?
November 16, 2022California’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 […]
Read More$30 Insulin Coming to California!
April 5, 2023CHANGES 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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