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EU to implement controversial drug manufacturing legislation

JURIST

The EU Wednesday released a draft of its proposed overhaul of drug manufacturing laws. The changes have caused controversy among manufacturers, with some stating they will leave the region if the laws take effect. However, the changes sparked some pushback from the drug manufacturing industry.

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Biden administration proposes climate regulations to lower US vehicle emissions

JURIST

The Environmental Protection Agency’s (EPA) proposed rule making details two initiatives to target greenhouse gas emissions from vehicles, applying to model years 2027 to 2032. Those affected by the rule include vehicle manufacturers and vehicle importers.

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New York City’s Building Electrification Law Wins in District Court

ClimateChange-ClimateLaw

City of New York , plumbing and building trade groups challenged New York Citys Local Law 154 of 2021 , a piece of legislation that prohibits fossil fuel combustion in most new buildings. This blog post discusses Local Law 154, unpacks Judge Abrams decision, and ends with a refresher on California Restaurant Association v.

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EU approves regulation to reduce CO2 emissions of heavy-duty vehicles

JURIST

The European Union approved on Monday a law to regulate carbon dioxide (CO2) emissions of heavy-duty vehicles to a stricter standard. The regulation will be signed and published in the Official Journal of the EU and will be reviewed by the European Commission in 2027. The regulation proposes various objectives.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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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.

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USDA Proposes New “Made in the USA” Standard

Customs & International Trade Law

The exception to this is for textile, wool, and fur products as processing or manufacturing occurring in the U.S. billion by 2030 ; and that, The global egg market is expected to grow annually by 7.70% (CAGR 2023-2027). be labeled with “Made in USA” or allude to any other indication of U.S. must be disclosed.