Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024
Agency IQ
MAY 3, 2024
The following PDUFA dates were obtained from publicly available sources.
Agency IQ
MAY 3, 2024
The following PDUFA dates were obtained from publicly available sources.
Agency IQ
JUNE 2, 2023
6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.
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Agency IQ
OCTOBER 6, 2023
All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.
Agency IQ
FEBRUARY 12, 2024
Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)
Drug Discovery World
NOVEMBER 9, 2023
Thereafter, there will be two presentations, which are: Jan Terje Andersen, PhD, Professor, Department of Pharmacology, University of Oslo; Research Group Leader, Department of Immunology, Oslo University Hospital, on: ‘Biology-based engineering of versatile antibody and albumin technologies’.
Agency IQ
SEPTEMBER 29, 2023
Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)
Agency IQ
FEBRUARY 15, 2024
We have tried to sort guidance documents by topic area. Priority B List.
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