Clinic Government Manufacturing Presentation 
FDA Law Blog
JANUARY 18, 2022
This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”
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
MARCH 3, 2024
This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.
FDA Law Blog
JANUARY 18, 2022
This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”
FDA Law Blog
OCTOBER 1, 2024
District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). FOOD AND DRUG ADMINISTRATION FOIA – FDA Presentation Pending 1:2023cv02325 (D.D.C.)
FDA Law Blog
MARCH 1, 2023
FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).
FDA Law Blog
OCTOBER 25, 2021
Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted
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