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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 reforms fall within the greater EU health plan from 2021 to 2027, where one of the goals is the affordability of medicine for members.

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Highlights from FDA’s Draft MDUFA V Commitment Letter

FDA Law Blog

MDUFA V would be applicable to fiscal years 2023 through 2027. FDA published in the Federal Register a draft version of its MDUFA V commitment letter , which outlines FDA’s updated performance goals in reviewing device applications and planned process improvements.

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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

Officials must first draft and adopt the rules to govern the program, including the regulation of wholesalers and dispensaries, cultivation and retail licenses, as well as the creation of new taxes and a five-member control board that will oversee the industry. billion by 2027. billion by 2027, depending on the rules and regulations.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

FDA also released, in December 2021, draft guidance for Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.”

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AI Applications for 5 Different Legal Fields

LawTechnologyToday

Legal firms spent approximately $12 billion on AI in 2017, and experts expect that figure to reach $85 billion by 2027. Corporate lawyers can use AI to ensure they draft the most beneficial contracts for their clients. Similarly, these programs can highlight errors or points of contention in drafts from the other party.

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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.