New Drug Approvals

APRIL 19, 2025

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. August 2000). 68 (2): 14350. doi : 10.1067/mcp.2000.108733.

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Agency IQ

JULY 8, 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.

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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.

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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Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance.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.

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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New Drug Approvals

APRIL 18, 2025

January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. Article ] Rosati G: Clinical pharmacology of iomeprol. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024. ^ New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report).

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