FDA Law

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S 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. 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The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” We have recently blogged on this topic (“ Is my software a medical device? ”). Special 510(k)s.

Specialization 105

Specialization Provider Medical Manufacturing 105

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

MARCH 9, 2025

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here. Well see you at the conference!

Manufacturing 59

Manufacturing Specialization Provider Management 59

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device.

Specialization 40

Specialization Clinic Provider IT 40

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