2016 Government Manufacturing Patients 
FDA Law
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.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).
FDA Law
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.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).
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FDA Law
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This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).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 Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).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
OCTOBER 10, 2022
The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.
FDA Law
SEPTEMBER 14, 2021
This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. 3, the Elijah E. 8126 with a lower MFP.
FDA Law
JUNE 1, 2025
Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.
FDA Law
MAY 19, 2022
By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C. See 42 C.F.R. §§ 447.505(c)(8)-(12).
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