FDA Law Blog

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 Entertainment Drafting 52

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

Manufacturing 64

Manufacturing Healthcare Drafting Statute 64

The Fashion Law

SEPTEMBER 13, 2021

percent from 2021 to 2028. As China continues to be a leading manufacturer and supplier to overseas markets, including but not limited to Southeast Asia, with its B2C and B2B platforms acting as crucial elements in the distribution chain, an enforcement strategy that does not specifically consider China would be woefully deficient.

Entertainment 76

Entertainment Manufacturing Drafting Laws 76

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Calendaring Statute Drafting 105