FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Labs must also begin complying with device labeling requirements (21 C.F.R. Stage 2 (two years after issuance of the final rule) : Register with FDA as a device establishment and list LDTs performed, pursuant to 21 C.F.R. Part 801) and investigational device exemption requirements (21 C.F.R.

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Labelling 64

pharmaphorum

JANUARY 14, 2021

Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. Focus on customer engagement impact.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2. of the total expenditures for all Part D drugs in 2021.

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Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Pharmacy Times

JUNE 9, 2025

months versus 2.1 The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois.

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FDA Law Blog: Biosimilars

JANUARY 2, 2025

Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat. Therefore, manufacturers must maintain records for foods bearing a healthy claim unless it is clear from the foods mandatory labeling information.

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Labelling Documentation 52