FDA Law

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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. 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

JULY 29, 2024

The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry is intended to be a roadmap that first describes the change notification process outlined in 21 C.F.R.

Manufacturing 64

Manufacturing Complication Government IT 64

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

Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. However, there is no clinical trial on its effect on COVID 19 infection or its complications. To send a DM, use Telegram. References 1.

Vaccination 52

Vaccination Government Physicals IT 52

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. But if you are a medical product manufacturer, the news of the termination of COVID-19 PHE could complicate your business plan.

Medical 98

Medical Manufacturing Provider Complication 98