ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

FDA 98

FDA Insurance Chemotherapy Documentation 98

The FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The announcement in the Unified Agenda of a planned NPRM is the most concrete evidence that FDA is moving forward with this plan. See , e.g. , ACLA White Paper on LDTs here. Javitt & McKenzie E.

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FDA Documentation 56

ISPE

JULY 5, 2023

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

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FDA Dosage Documentation Pharmaceutical Companies 52

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For more information on this, please download our white paper. For more information, please download our white paper.

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Vaccines Documentation FDA 52

ISPE

SEPTEMBER 11, 2023

FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. September 2022. 25%20from%202022%20to%202027 24 Eglovitch, J. 7 March 2023.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

NOVEMBER 3, 2022

The regulatory keynote was delivered by Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), US FDA. Marks outlined some concepts that the FDA is thinking about that could help move in this direction, such as developing a “cookbook” to standardize bespoke product development and manufacturing.

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Communication FDA Documentation Vaccines 98

Pharmaceutical Technology

MARCH 2, 2023

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This publication marks the FDA’s proactive steps to ease the pharmaceutical’s industry transition to these advanced processes, states the announcement.

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FDA Documentation Communication 84

The FDA Law Blog

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.”

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Documentation 69