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Nanoparticles: Emerging Stars for Pharmaceutical Industry

Roots Analysis

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. 3.1.1: Bioavailability Study Reports.

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Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

The FDA Law Blog

Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act). By Faraz Siddiqui & Deborah L.

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New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

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New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act – Final Guidance. By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

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New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act – Final Guidance. By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.