FDA Law

FEBRUARY 13, 2025

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

Manufacturing 71

Manufacturing Management Specialization Provider 71

Minnesota Academy of Family Physicians

MARCH 27, 2025

The bill passed by a voice vote and was referred to the State and Local Government Committee. Schools are seeing increased concerns related to managing acute and chronic health conditions, mental health issues and health fragility. This will trigger a special election in District 6. Read a summary of S.F. Read a summary of S.F.

Family Physician 52

Family Physician Insurance Finance Individual 52

FDA Law

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections.

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections.

Management 40

Management Manufacturing Specialization IT 40

FDA Law

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

Management 59

Management Manufacturing Specialization Government 59

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there.

Healthcare 128

Healthcare IT Education Community 128