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With the ink on the president’s signature barely dry, the commissioner of the U.S. Food and Drug Administration (FDA) – Dr. Scott Gottlieb – issued a statement letting everyone know that the agency is aware of the implications of the Agriculture Improvement Act of 2018 (a/k/a the Farm Bill). As we reported last month, CBD derived from hemp may not be “marijuana” any longer, but the laws that the FDA enforces continue to prohibit (at…
Signed into law on December 20, 2018, the 2018 Farm Bill may present a tremendous opportunity for banks and payments companies to provide banking, processing, and other services to the hemp industry. We expect a variety of companies to move swiftly in developing, marketing, and selling products (including CBD oil) that, until yesterday, were controlled substances. This means that banks and payment processors should be prepared for a flood of inquiries from the industry about…
On consecutive days last month, both the Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) made clear that delays in reporting potential product hazards or defects could significantly damage a company’s reputation and bottom line. The message from these agencies is clear—manufacturers and distributors of products regulated by CPSC and/or FDA would be wise to ensure their product quality processes and compliance programs enable swift communication to regulators and the…
Draft guidance documents propose a framework for clinical and patient decision software and explain policy changes driven by 21st Century Cures Act Final guidance document adopts International Medical Device Regulators Forum principles for addressing “clinical evaluation” of Software as Medical Device Public Workshop (January 2018) will discuss progress of pilot precertification program The FDA’s December 8 announcement of the availability of three new guidance documents, and of a public workshop to be held in January…
Opens application process and public comment period for precertification pilot program Nine companies to be chosen by September 1, 2017 Last June, FDA Commissioner Scott Gottlieb made his first public statement as Commissioner by announcing the imminent rollout of a new “Digital Health Innovation Plan.” This statement signaled his intent to prioritize the agency’s efforts to create – and clearly articulate – a regulatory regime that promises to “help innovators navigate a new, modern regulatory…