Genotoxicity Marketing Regulation 
The Pharma Data
FEBRUARY 8, 2021
IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. IBRANCE may impair fertility in males and has the potential to cause genotoxicity.
The Pharma Data
MARCH 25, 2021
IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. IBRANCE may impair fertility in males and has the potential to cause genotoxicity.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
XTalks
MAY 13, 2022
Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.
FDA Law Blog
NOVEMBER 20, 2024
For FDA submissions, this strategy can be used to evaluate the biocompatibility endpoints acute, subacute, subchronic, and chronic systemic toxicity, genotoxicity, carcinogenicity, and reproductive/developmental toxicity. BEP/BER or Biological Risk Assessment) per ISO 10993-1 is not required for the majority of FDA pre-market submissions.
Expert insights. Personalized for you.
52 
Let's personalize your content