Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this 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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The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. 2,3 In the U.S.,

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FDA Law Blog: Biosimilars

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. The pandemic had changed the way people live, work and communicate. Such changes are not limited to personal circumstances.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). 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. By Jeffrey N.

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FDA Law Blog: Biosimilars

NOVEMBER 22, 2023

FDA subsequently established an interim food additive regulation, codified at 21 C.F.R. §  180.30 , which authorizes the use of BVO as a stabilizer for flavoring oils in an amount not to exceed 15 ppm in the finished fruit-flavored beverage. In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

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FDA Law Blog: Biosimilars

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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