FDA Law

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S As the co-founder of HP&M’s FDA Law Blog , Kurt often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. We can offer our readers a special discount for the event. S for reduced registration fees.

Management 59

Management Manufacturing Specialization Government 59

FDA Law

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

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. We will discuss these actions in more detail in later blog.

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. We will discuss these actions in more detail in later blog.

Management 40

Management Manufacturing Specialization IT 40

FDA Law

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

Private Practice 52

Private Practice Specialization Government Management 52

FDA Law

APRIL 6, 2025

Andrew draws on his government experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now represent clients facing those issues. We look forward to her development and future success here, said HPM Managing Director J.P. Ellison.

IT 59

IT Nurse Practitioner Patient-Centered Specialization 59

FDA Law

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. DEA regulations require “adequate security” but do not specially require cameras in health care facilities. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36

Board-Certified 52

Board-Certified Provider Government Management 52