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FDA Guidance for industry titled Changes to Disposable Manufacturing Materials: Questions and Answers

FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited availability of disposable manufacturing materials during periods of increased demand (e.g., public health emergencies or natural disasters). Limited availability of disposable manufacturing materials can affect sterile drugs and biological products. This guidance describes chemistry, manufacturing, and controls (CMC) post-approval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing. Applicants should use science-based and risk-based principles, and current FDA guidances for industry, to determine the appropriate reporting category to communicate changes to disposable manufacturing materials.

This guidance applies to biologics license application (BLA) products; human drug products marketed as new drug applications (NDAs) or abbreviated new drug applications (ANDAs); and animal drugs marketed as new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs). This guidance also applies to all manufacturing establishments, including those that perform functions under contract as defined in the guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements [FDA]

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FDA: Hope for user fee reauthorization

While the US Food and Drug Administration has warned that it would need to lay off staff in the first...

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Farmaci biosimilari in Italia: report AIFA aggiornati a maggio 2022

L’Agenzia pubblica i report sul monitoraggio dei farmaci biosimilari in Italia, aggiornati ad maggio 2022. Oltre...

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Impact Factors for Sourcing

How is current market volatility, led by inflationary pressures, supply-chain disruptions, and geopolitical...

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AIFA - Synchron Research Service: il riesame conferma la sospensione di medicinali a causa di irregolarità negli studi

Il Comitato per i medicinali per uso umano (CHMP) dell'EMA ha confermato la propria raccomandazione...

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