European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Yet in 2021, 100 nanomedicines had been marketed.

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Process Improvement Packaging Vaccines FDA 73

The FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” Opportunity for feedback from FDA if provided pre-BLA. By Holly N.

FDA 59

FDA Process Improvement 59

ISPE

SEPTEMBER 11, 2023

3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24. 5 October 2022. 18 May 2022. Environmental Monitoring for Closed Robotic Workcells Used in Aseptic Processing: Data to Support Advanced Environmental Monitoring Strategies.” 6 (2022):215. 16 February 2022. 1 (2021):48.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Published online (24 May 2022).

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Process Improvement Packaging Dosage Compounding 98

ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. HC is expected to have full implementation of ICH Q12 by late 2022. Cauchon, PhD.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. 2022) [link] 8 Kendsersky, B., Robinson, G.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. 2022) [link] 8 Kendsersky, B., Robinson, G.

Documentation 52

Documentation Dosage Packaging Communication 52