Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

AUGUST 2, 2024

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes | Oct 25, 2023 5:20 PM CDT | Updated Jul 31, 2024 10:17 PM CDT What we expect to be talking about in August and September Based on our scanning, AgencyIQ expects that August will be another sleepy summer month for European regulators.

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