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EU-funded project encourages use of simulation in drug development

pharmaphorum

It will also produce policy documents and information packages for patients, doctors and senior management in companies, Other workstreams could include computational strategies to make such simulations more powerful and efficient, new curricula to educate the workforce on the development and use of the technologies.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

The FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Many organizations already have documented process maps.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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Omnicell and Fresenius Kabi Join Forces to Improve Controlled Substance Management

Omnicell

million doses were diverted in 2018, equal to the population of Arizona and California combined. Hospitals are already using Fresenius Kabi Simplist® MicroVault® prefilled syringes to help nurses spend less time preparing doses and documenting waste. And according to the 2019 Drug Diversion Digest , 47.2

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(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

The FDA Law Blog

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. much like an FDA guidance document. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. FDA must also review the list periodically.

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