Remove 2028 Remove Laws Remove Manufacturing
article thumbnail

A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

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.

article thumbnail

FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling

Customs & International Trade Law

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Brands Are Reaping Rewards, Facing Risks Due to the Rise of the Nearly $500 Billion Social Commerce Market

The Fashion Law

percent from 2021 to 2028. On a global level, developments in data protection regulation and privacy law have made it more difficult for law enforcement and investigators to collect data on online users. On a global basis, Grandview Research put the value of the global social commerce market size at $474.76

article thumbnail

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

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.