The FDA Law Blog
JANUARY 4, 2023
As previously m entioned , sponsors can interact with FDA in the town hall by submitting questions in advance or by asking a question live during the meeting. The Agency repeatedly stated and strongly recommends sponsors engage with FDA prior to submitting the IND. The workshop is also discussed in Cell & Gene here and here.
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. A main area to consider is connections, such as: Bridging industry 4.0 to a pharma-specific Pharma 4.0™ to a pharma-specific Pharma 4.0™
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ISPE
MARCH 29, 2023
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. Direct feedback from the US FDA on this pilot is shared in the discussion.
ISPE
MARCH 29, 2023
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. Direct feedback from the US FDA on this pilot is shared in the discussion.
Pharmaceutical Technology
JANUARY 24, 2023
The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.
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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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
DECEMBER 16, 2022
This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE).
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