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Scalable precision design targeting complex product profiles

Drug Target Review

Given the relevance of brain metastases in cancer patients, what are the pharmacokinetic properties that enable CNS penetration of LSD1 inhibitors? LSD1 demethylates histones which play a critical role in regulating the expression of genes that suppress differentiation and drive the proliferation and survival of several tumour types.

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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. In July, a new contract notice indicated that this is an area of interest for FDA as well.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis of a recent listening session on the topic here. ].

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Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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Medicare Coverage Analysis Worksheet

Advarra

Pharmacy manual. Safety, quality of life, and pharmacokinetic (PK) responses are not considered to be therapeutic objectives. The trial is in compliance with Federal regulations relating to the protection of human subjects. Identifies what items/services sponsor reimburses, and therefore not eligible for Medicare coverage.