FDA

Oral cannabidiol (CBD) is approved by the Food and Drug Administration (FDA) to treat patients with Dravet and Lennox-Gastaut syndromes, and tuberous sclerosis complex. The therapeutic potential of oral CBD formulations is limited by extensive first-pass hepatic metabolism. Following oral…
Read More...

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…
Read More...

Nanomedicines based on poly(lactic-co-glycolic acid) (PLGA) carriers offer tremendous opportunities for biomedical research. Although several PLGA-based systems have already been approved by both the Food and Drug Administration (FDA) and the European Medicine Agency (EMA), and are widely used in…
Read More...

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…
Read More...

On the 14th of November is the annual World Diabetes Day. The 2021 - 2023 theme is "Access to Diabetes Care". Millions of people with diabetes around the world do not have access to diabetes care. People with diabetes require ongoing care and support to manage their condition and avoid…
Read More...

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…
Read More...

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…
Read More...

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…
Read More...

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…
Read More...

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…
Read More...