FDA

Cannabidiol (CBD) is an alkaloid that can be found in the Cannabis species, currently used in United States of America under the name of Epidiolex®, which was approved by Food and Drug Administration (FDA) for seizures treatment. The purpose of this study was to investigate the structural…
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The year 2020 was an eventful year for the pharmaceutical industry, with several companies across the world working at a feverish pace to find a treatment or a vaccine for the raging Covid-19, which has so far taken over 1.79 million lives worldwide. With countries imposing lockdowns and…
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On the 14th of November is the annual World Diabetes Day. This year's theme is "The Nurse and Diabetes". Nurses currently account for over half of the global health workforce. They do outstanding work to support people living with a wide range of health concerns. People who either live with…
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In its continuous endeavor to bolster the competitiveness of the generics market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’. The agency updates this list every six months to improve transparency and to encourage…
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In case you thought Covid-19 had slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA), you are in for a pleasant surprise. During the first half of this year, the industry…
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High numbers of drug recalls persist despite the tremendous time and effort invested by pharmaceutical organizations and regulatory bodies such as the Food and Drug Administration (FDA) to ensure the quality of safe and effective medicines for the patient. It is imperative to better understand the…
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Do you want to use the USP Pending Monograph process? Or have you ever wondered what the USP Pending Monograph process is and how it works in detail? See our article explaining the PMP with a full overview or have a look at our summarizing video. Both are based on USP information. Moreover, you can…
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Statement from Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. at March 05, 2020 Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the…
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The United States Pharmacopeia (USP) appreciates the opportunity to provide comments on a potential FDA novel excipient review program. USP is supportive of a novel excipient review program. Establishing new pathways for the development and regulatory review of novel excipients is critical in…
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Innovation drives progress in the development of new drugs and therapeutic biological products. 48 new drugs and biological products were approved by the FDA last year, which means new treatment options for patients and considerable advances in health. The majority of these new drugs…
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