Roots Analysis

FEBRUARY 20, 2022

Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Our Social Media Platform. Web: [link]. LinkedIn: [link].

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

Drug Discovery World

FEBRUARY 2, 2023

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden 1 – the Modernization Act 2.0. may not materially change the current drug approval process at the FDA.

Drugs 52

Drugs Clinical Trials Clinical Trials Cosmetics 52

Camargo

AUGUST 22, 2021

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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Containment Bioavailability Cosmetics Packaging 190

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

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Trials Clinical Trials Clinical Trials Drugs 59