Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES | FEB 21, 2024 7:48 PM CST Background: Dose-finding in oncology Traditionally, early development of oncology products has focused on identifying the maximum tolerated dose (MTD) of an investigational product. She then provided two real-world examples of a CUI in action.

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Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

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Agency IQ

FEBRUARY 12, 2024

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, CDER, CDRH, CFSAN), as well as some additional FDA offices (like its Office of the Chief Scientist ). This list is known as the FDA’s “guidance agenda.”

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Agency IQ

JULY 28, 2023

This is referred to as “sole source” of a service, and might occur in situations where one company has a brand name product that does not have competition in the marketplace or could occur when a vendor retains significant advantage over competition (e.g., Industry wants its products reviewed quickly, efficiently and predictably.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

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The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

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The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)].

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New Drug Approvals

APRIL 18, 2025

equivalents, the compound of formula (4) can be obtained in reasonable yield with minimizing the generation of the compound of formula (5) which is a bismer by-product. That is, the by-product of the compound of formula (21) can be removed even without an additional removal procedure. to 1 equivalents, more preferably in 0.7

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New Drug Approvals

APRIL 21, 2025

The crude product was subjected to flash column chromatography (silica gel, 10-50% MeOH/CH 2 Cl 2 ) to give Compound VIIc (68 mg, 71% yield) as a white solid (>98% purity by HPLC); 1 H NMR (CD 3 OD, 600 MHz) 7.65-7.58 The reaction mixture was stirred at room temperature for 14 hr after which it was cooled to 0 C. 7.58 (m, 2H), 7.20-7.14

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