2016 Government Manufacturing Provider 
FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).
FDA Law Blog
JANUARY 15, 2024
Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.
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FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).
FDA Law Blog
JANUARY 18, 2023
Recall that CMS is required to negotiate and publish the 2016 maximum fair price for 10 high expenditure, single source Part D drugs by September 1, 2024. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance.
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This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).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. What’s new in the new Draft Guidance? Not all that much. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.
FDA Law Blog
APRIL 19, 2021
The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug.
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