Documentation FDA White Paper 
Pharmaceutical Technology
FEBRUARY 8, 2023
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.
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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The FDA Law Blog
OCTOBER 10, 2022
Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”
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.
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.
ISPE
JULY 19, 2023
This includes ensuring maturity levels for all operating model elements follow the five general maturity levels defined by the FDA: 1–Initial, 2–Developmental, 3–Defined, 4–Managed, and 5–Optimized. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? to a pharma-specific Pharma 4.0™
ISPE
MARCH 29, 2023
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Published 15 November 2021.
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