ISPE

JULY 6, 2023

This has stemmed from a lack of familiarity with the “new to pharma” technology among global regulatory bodies, or at least the perception thereof. 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published July 2021.

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Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

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The FDA Law Blog

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats. Tobolowsky — Much has changed since the long-gone days of 2017.

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The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. . § Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest.

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ISPE

SEPTEMBER 11, 2023

There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the advantages of advanced and decentralized manufacturing techniques.

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ISPE

JUNE 21, 2023

The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without the need for the printing of paper test documents. Is there a gap in features from the vendor/technology side?

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ISPE

OCTOBER 28, 2022

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. The Road to Advanced Manufacturing. The ability to do so probably saved lives.”.

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ISPE

AUGUST 29, 2022

Streamlining Postapproval Submissions Using ICH Q12 & SCDM. Streamlining Postapproval Submissions Using ICH Q12 & SCDM. Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Trudy Patterson. Mon, 08/29/2022 - 15:46. September / October 2022.

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ISPE

JULY 7, 2023

4 , 5 Other challenges reflect the cautious nature of pharmaceutical manufacturing, like risk aversion and regulatory considerations. This article summarizes trends from the workshop and ponders next steps. 1 Some advantages are apparent based on the nature of a continuous processing, including higher efficiency at lower cost. Bi, and A.

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ISPE

AUGUST 30, 2022

Regulatory Landscape for Raw Materials: CMC Considerations. Regulatory Landscape for Raw Materials: CMC Considerations. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Trudy Patterson. Mon, 08/29/2022 - 20:53. Jacqueline E.

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