FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 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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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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FDA Law Blog: Biosimilars

DECEMBER 12, 2024

Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. A limited number of affidavits may be received into the record subject to the evidentiary weight adjustment specified in the regulations. Prehearing Ruling (Dec. 4, 2024), at 1.

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FDA Law Blog: Biosimilars

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M. 21 CFR 820.20

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The Pharma Data

MAY 18, 2021

Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. About Sandoz.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. In FY 2025, continue to support products enrolled in previous fiscal years and expand to enroll up to 65 additional products in at least four OHTs (i.e.,

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. The draft guidance indicates that this timetable will be announced by September 30, 2025. There will be a transition period before requiring all De Novo requests to be submitted electronically.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. CAPITAL ALLOCATION. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S. billion on revenues and approximately $0.09

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations. The federal telemedicine flexibilities (i.e.,

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FDA Law Blog: Biosimilars

MAY 23, 2024

Gonzalez — On May 15th and 16th, respectively, Senator Rand Paul and Congressmen Brad Finstad and Dan Crenshaw introduced Senate and House resolutions “providing for congressional disapproval under chapter 8 of title 5, United States Code” of FDA’s Final Rule to regulate Laboratory Developed Tests (LDTs).

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