JURIST
DECEMBER 29, 2020
The US Environmental Protection Agency (EPA) on Monday announced that the agency is in the process of adopting its final greenhouse gas (GHG) emissions standards that will apply to certain new commercial airplanes manufactured in the US, including all new large passenger planes and commercial jets.
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)
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FDA Law Blog
JANUARY 18, 2023
The topics focus on issues relevant in the first three years of the Negotiation Program—2026 to 2028. They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. Approach for considering (1) the manufacturer-reported data elements and (2) evidence about alternative treatments.
Customs & International Trade Law
JANUARY 10, 2025
What Food Manufacturers Should Do The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a healthy label meets the new criteria.
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.
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.
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.
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