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. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

Manufacturing 52

Manufacturing Government IT Complication 52

FDA Law

JULY 13, 2022

With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. As a threshold matter, the 2-year delay provision does not solve the core problem for biosimilars manufacturers: the lack of predictability that Build Back Better injects into biosimilar development.

IT 52

IT Manufacturing Utilities Complication 52

FDA Law

JANUARY 11, 2024

Important to note here is that each interchangeable biosimilar was first approved as a biosimilar and each biosimilar manufacturer had been sued under the so-called “patent dance” procedure prior to seeking licensure of the biosimilar products as interchangeable. This all sounds complicated, I know.

Provider 59

Provider IT Manufacturing Complication 59

FDA Law

OCTOBER 14, 2022

The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. FDA provides FAQs about what happens to EUAs when a public health emergency ends (see here ). We all look forward to the end of the COVID-19 pandemic.

Medical 98

Medical Manufacturing Provider Complication 98