Compliance Insulin Regulation 
Camargo
OCTOBER 14, 2020
The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Senior Director of Regulatory Compliance and Submissions. Contact us to find out how we can support your program. Co-Authors: Ken Phelps.
Pharmaceutical Technology
AUGUST 31, 2022
Devices such as insulin pumps, heart pacemakers, and inhalers can track patient data in real-time and transmit to the user’s phone, an app, or their doctor, making the data immediately accessible, and often keeping the patient out of the hospital.
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Pharmaceutical Technology
DECEMBER 15, 2022
When choosing an antimicrobial API, it is very likely that local regulations will demand a cGMP ingredient. In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. Full compliance to both monographs and general notices and chapters is recommended.
FDA Law Blog
JANUARY 5, 2023
Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. One example is the Warning Letter FDA sent to Medtronic in late 2021 concerning a vulnerability in insulin infusion pumps.
FDA Law Blog
APRIL 11, 2022
Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. This estimation of risk is important because it drives both decision making and regulatory compliance. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps.
XTalks
JUNE 12, 2023
Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor. Significantly, Roche received full compliance under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) from the European Union. It also plans to launch these products in the US.
FDA Law Blog
DECEMBER 3, 2023
covered insulin product or vaccine). Audits and Compliance Monitoring: Using its discretionary authority under 42 U.S.C. CMS may similarly audit participating manufacturers up to once a year to monitor their compliance after a similar 60-day notice of a reasonable basis for the audit. state pharmaceutical assistance programs).
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