FDA

Pharmaceutical 3D printing (3DP) has attracted significant interest over the past decade for its ability to produce personalised medicines on demand. However, current quality control (QC) requirements for traditional large-scale pharmaceutical manufacturing are irreconcilable with the production…
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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 adoption of these advanced manufacturing technologies. FDA has…
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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 review, the FDA has concluded that a new regulatory pathway…
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Pediatric formulations often contain excipients with lack of safety and toxicity data based on a unique and daily exposure, duration of treatment and patient acceptability. In the 1980s, US set up regulatory initiatives for the development of pediatric drugs. In 2007, pediatric regulation focused on…
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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 accepted their excipient, Soluplus®, into the FDA’s Pilot…
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Males and females respond differently to medications due to physiologic, metabolic, and genetic factors. At times, sex-related differences cannot be mitigated by dose adjustment to body mass, and are evident from the tissue level to the single cell. The rising number of clinically approved…
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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 mPEG-PDLLA pharmaceutical excipient in the review cycle of the FDA…
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CDER scientists are seeking ways to improve the bioavailability of drugs that on their own do not dissolve well in water. Recent CDER research explores the potential for using amorphous solid dispersions to formulate generic drug products that may include ingredients that are poorly water-soluble.…
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In this paper, we have studied Wurster Coating operation for the manufacture of modified release (MR) capsule products submitted to FDA as New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) by using a data-driven approach. We have collected and classified information into…
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Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility.…
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