Category US FDA

Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies

Last updated: 18 March 2023 See updates at the end of this post. This post is an attempt to provide some basic information on Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies. An important limitation…

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US FDA Announces Proposed Rule for Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU)

The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0862 on Regulations.gov. …

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FDA updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products

The FDA has recently updated its information on possible mitigation strategies to reduce the risk of nitrosamine drug-substance related impurities in drug products (NDSRIs). Guidance for industry on nitrosamine was published in September 2020 and updated in February 2021. A…

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