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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.

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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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New York Reaches Agreement to Legalize Adult-Use Marijuana

Hoban Law Group

Following a three-way agreement between the New York Assembly, Senate, and the governor’s office, the new law will permit the cultivation, distribution and sale of cannabis in New York subject to state regulations. . billion by 2027. billion by 2027. billion by 2027, depending on the rules and regulations.

Legal 94
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AI Applications for 5 Different Legal Fields

LawTechnologyToday

But what about practicing law? Legal firms spent approximately $12 billion on AI in 2017, and experts expect that figure to reach $85 billion by 2027. As these technologies continue to improve, AI in law will only grow. AI in law is a relatively new and continually expanding concept. Criminal Law. Corporate Law.

Legal 131
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This Week in Regulation for Broadcasters:  May 8 to May 12, 2023

Broadcast Law Blog

On a rolling basis through April 1, 2027, stations licensed in all other states will be subject to the Mid-Term Review on the fourth anniversary of the filing deadline for their most recent license renewal application. The upload of the public file report by a TV station means that the mid-term review of its EEO performance is required.

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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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Why Legal Process Outsourcing is the right choice for you?

Cenza

During the COVID-19 pandemic, corporate legal departments and law firms around the world struggled to meet the new normal’s demands. The global legal process outsourcing (LPO) market, which is predicted to reach US$30 billion by 2027 , has surged as a result of this influence. Why Does LPO Matter? The market size says it all.