Biosimilars Definition Pharmacokinetics 
FDA Law Blog: Biosimilars
JULY 23, 2024
Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.
FDA Law Blog: Drug Discovery
FEBRUARY 2, 2023
The definition goes on to list potential options for such tests: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods such as bioprinting, as well as animal tests. For more on FDORA’s other provisions, see HPM’s complete summary here ). FDORA § 3209(a)(2).
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Agency IQ
JULY 26, 2024
FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.
Agency IQ
FEBRUARY 12, 2024
Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.
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.
FDA Law Blog: Biosimilars
MAY 21, 2024
The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. The proposed rescheduling would not apply to synthetically derived THC outside of the CSA definition of marijuana, which would remain in schedule I. Basis at 24.
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