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.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).
FDA Law
OCTOBER 3, 2022
For example, the government closely scrutinizes speaker programs or trainings that involve lavish venues or meals and free alcohol, invite attendees with no legitimate business reason to attend, and present little substantive information to them. The Alert described several factors that could potentially violate the antikickback statute.
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FDA Law
MARCH 6, 2024
HP&M is proud to have our professionals participating in these important events. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. We can offer our readers a special discount for the event.
FDA Law
AUGUST 26, 2021
In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.
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.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).
FDA Law
JUNE 2, 2025
Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision. By Steven J.
FDA Law
JANUARY 5, 2023
But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. FDA has shown a willingness to intervene in this space.
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