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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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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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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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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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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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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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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. We, and many stakeholders, agree that RWD and RWE can play an invaluable role.