Abstract EMA and FDA are upgrading guidelines on assessing the quality and the equivalence of topically applied drug products for developing copies of originator products and supporting post-marketing variations. For topical products…

Abstract Background Modified Release (MR) orally administered drugs products differ from Immediate-Release (IR) drug products in their drug release site and/or rate to offer therapeutic advantages. It is important to understand the…

FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products in March 2023. The document represents, according to FDA, a proactive step the FDA is taking to facilitate the pharmaceutical industry’s…

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful…

This review describes the recently FDA-approved drugs (in the year 2022). Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient or as part of a combination. These products…

Florham Park, New Jersey, December 5, 2022 – BASF Pharma Solutions, a global business unit of BASF, announces today that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of New Drugs, has…

Abstract Alzheimer’s disease (AD) is the most common form of dementia, with a high impact worldwide, accounting for more than 46 million cases. The continuous increase of AD demands the fast development of preventive and curative…

WILMINGTON, Del., Oct. 31, 2022 -- Ashland Inc. (NYSE: ASH) today announced the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research Office of New Drugs has accepted Ashland Viatel™ bioresorbable…

Purpose Mixing with liquids or soft foods is a common procedure to improve acceptability of oral medicines in children but may affect drug stability and the in vivo performance of the administered drug product. The aim of the present study…

The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. Article by Asher Mullard - Nature Reviews Drug Discovery - 04 January 2022 The FDA’s…