High Hopes: HMD/IOM’s 2017 Report on the Health Effects of Cannabis and Cannabinoids

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By: Robert G. Bell

bell-headshotLast week, the Health and Medicines Division (HMD), formerly the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering and Medicine, released their report “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017),” which entails a comprehensive review of the literature (>10,000 citations reviewed) regarding the health effects and potential therapeutic uses of cannabis and its constituents on 11 groups of health outcomes.  Continue reading

Internal Struggles At FDA Over Sarepta Approval Show That Science, Consensus Not Important

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By Ben Locwin

linkedinpicRecently, the Food and Drug Administration (FDA) approved Sarepta’s drug eteplirsen on an accelerated timeline for the treatment of Duchenne muscular dystrophy, which has a potential market of 1 in every 7,250 males aged 5–24 years in the United States alone. Continue reading

Why Is It Important to Get FDA Process Validation Right?

By: Edward Simpson

edward_imgProcess validation is the guiding principle that ensures consistency, quality, and safety of products in every unit that manufactures food and drugs. It is an ongoing process that plays a vital role in the designing, prototyping, and manufacturing of food and drug products. The Food and Drug Administration (FDA) process validation enlists various concepts and components that manufacturers must adhere to in order to achieve the desired product performance and quality. Strict adherence to these standards and specifications is needed for an FDA approval, which also ensures the well-being of the end-user. Process validation also improves process capabilities, lowers scrap, and increases the yield while lowering the cost of production. Continue reading

Eye-opening research: finding solutions to problems experienced by patients using Nepafenac

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By: Haley Porter

photo_haley-porterNepafenac is a common NSAID used to treat pain and inflammation in the cornea following Lasik or cataracts surgery. Nepafenac is very lipophilic; therefore, it is currently only available as a commercial suspension. Continue reading

Abuse-Deterrent Technologies: One Step in the Opioid Epidemic but, How to we Evaluate Them?

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By: Chris Altomare

headshot2Over the past two decades, the increased use of opioids for legitimate medical purposes has been paralleled by a substantial increase in nonmedical use and abuse of opioids. The numbers are alarming and have risen to epidemic proportions. According to the Centers for Disease Control and Prevention, nearly 2 million Americans abused or were dependent on prescription opioids. Overdose deaths involving prescription opioids have quadrupled since 1999, with 165,000 people dying of overdoses related to prescription opioids from 1999 to 2014. Continue reading