Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024
Agency IQ
JULY 8, 2024
The following PDUFA dates were obtained from publicly available sources.
Agency IQ
JULY 8, 2024
The following PDUFA dates were obtained from publicly available sources.
Agency IQ
FEBRUARY 2, 2024
The following PDUFA dates were obtained from publicly available sources.
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Agency IQ
JUNE 16, 2023
The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ] the drug and device) of the combination product.
Agency IQ
FEBRUARY 15, 2024
CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.
Agency IQ
OCTOBER 27, 2023
WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.
Agency IQ
JULY 12, 2024
A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.
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