FDA Law

JANUARY 8, 2024

Moreover, it requires not only an understanding of what the laws say, but how what the government would be expected to do in the future based on the regulatory compliance history. Deals in FDA regulated space are among the most complicated of any industry, and diligence adds cost.

Complication 69

Complication Government IT 69

FDA Law

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. By Karla L. Palmer & John A.

Supply Chain 52

Supply Chain Provider Government Complication 52

FDA Law

NOVEMBER 16, 2021

5376 that would implement the “Program” get pretty complicated from there. While this blogger does not have any particular comments on whether or not the idea of government drug price negotiation is good or bad, the way it has been structured in H.R. 4) carry out the administrative duties described in section 1196.

Manufacturing 52

Manufacturing Government IT Complication 52

FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. By David B. Clissold & Sara W.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law

JULY 29, 2024

The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy.

Manufacturing 64

Manufacturing Complication Government IT 64

FDA Law

JANUARY 11, 2024

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. This all sounds complicated, I know. With the ambiguity of the statutory text, FDA looked at the plain language, context, and the structure and purpose of the statute—including both parties’ positions on those points.

Provider 59

Provider IT Manufacturing Complication 59

FDA Law

JULY 13, 2022

With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. Karst — The Build Back Better Act—the food and drug law implications of which we discussed last year —has popped up again in Congress, and it is just as dense as ever. Each product is limited to two years of delay.

IT 52

IT Manufacturing Utilities Complication 52