FDA Law Blog
NOVEMBER 27, 2023
the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. At the time, in 2016, the Gree Companies’ settlement for $15.45 The government charged these individuals with conspiracy (18 U.S.C. § See 15 U.S.C. § 2070.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
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FDA Law Blog
FEBRUARY 21, 2024
It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.
FDA Law Blog
APRIL 22, 2024
When DEA denied marijuana rescheduling petitions in August 2016, cannabis was listed as a schedule I and schedule IV substance under the Single Convention. marijuana manufacturers, importers, exporters, and distributors will be required to obtain DEA registrations, and prescriptions will be required for dispensing marijuana to individuals.
FDA Law Blog
AUGUST 8, 2024
Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 53,688 (Aug. 53,767 (Aug.
FDA Law Blog
SEPTEMBER 6, 2022
This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).
FDA Law Blog
OCTOBER 5, 2022
The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).
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