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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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What does the FDA animal testing legislation mean for drug discovery? 

Drug Discovery World

As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. As reported by DDW , the system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models.

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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. 2.3.2: Repeat-Dose Toxicity.

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

FDA Law Blog

Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act). This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol.

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