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FDA’s CRLs reveal 74% of applications rejected for quality, manufacturing issues

Pharma Manufacturing

Out of 202 Complete Response Letters issued between 2020 and 2024, 150 involved quality/manufacturing issues, according to the regulator’s newly released documents.

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

COM(2020) 761 final. Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 2020;25(11):1910-1918. Biosimilar Medicines: Overview. European Medicines Agency. Pharmaceutical Strategy for Europe.

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Warning Letters: An Untapped Source for Understanding When Device Changes Require a New 510(k)

FDA Law Blog: Biosimilars

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Notably, FDAs public WL database only goes back to 2020. See 21 C.F.R.

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Investment Banking Trends: AI, US Fed rates, and private credit with Gaurav Bhasin

Fuld & Company Blog

Overall, the market for later-stage financing has improved from 2022/23 but not to 2020 levels, which is healthy for the eco-system. However, top-tier companies in the AI space, such as Open AI and Databricks, with astronomical growth, have been able to attract capital at peak valuations.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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Optimizing Your Drug Patent Strategy: A Comprehensive Guide for Pharmaceutical Companies

Drug Patent Watch

Proactive measures to protect your patents include: Regular patent portfolio reviews Monitoring competitor activities Maintaining detailed lab notebooks and documentation Implementing strong trade secret protections By staying vigilant, you can often prevent infringement before it occurs or strengthen your position if litigation becomes necessary.

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5 Years of Home Infusion Therapy Pharmacy Accreditation

National Association of Boards of Pharmacy

This includes an online renewal application where pharmacies provide supporting documents confirming compliance with the accreditation standards. NABP was first granted deeming authority by CMS to award Home Infusion Therapy Pharmacy Accreditation in 2020 and is currently one of 6 approved accrediting organizations.