DEA Moves Cannibidiol to Schedule V of the Controlled Substances Act
In a move that could eventually open the door to more FDA drug approvals for medicines that contain cannabidiol, the DEA last week, moved FDA-approved drugs with CBD to Schedule V of the Controlled Substances Act. The order puts drugs that have been approved by FDA and have no more than .1% of tetrahydrocannabinol or […]
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Tips for Implementing a Root Cause Failure Analysis Program
Implementing a root cause failure analysis program at a pharmaceutical facility can be challenging, especially when failures do not affect the quality of the product. Including failures that are not related to quality in your root cause failure analysis program can bring much value to a drug company. There are three major factors for your […]
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FDA Approval of Cannabis-Based Drug Will Lead to More Medications
The CEO of GW Pharmaceuticals, Justin Grover, said last month that his company’s new cannabis-derived drug that was approved by FDA for treating epilepsy will pave the way for other drugs based upon marijuana. FDA has approved the new epilepsy drug called Epidiolex. Gover said in an interview this summer that the FDA drug approval […]
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Estabilishing a Legal Cannabis Business – What To Know
Cannabis is a big business in the US states that have made its recreational use legal, even though it is still defined at the federal level as a Schedule 1 controlled substance. The US government generally is not intervening in the states that allow legal cannabis businesses. However, its cloudy legal status at the federal […]
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Using Root Cause Analysis to Find Pharmaceutical Manufacturing Deviations
Investigating the cause of a drug quality failure is something that all drug manufacturers must do, and some must do so more frequently than others. FDA 483s and warning letters often cite improper corrective and preventive action (CAPA) as a major problem with compliance. How do you ensure that your CAPA program is on the […]
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Overview of High-Quality Cannabis Processing
‘Cannabis extraction’ is a blanket term that is often used in place of cannabis processing. A high-quality cannabis process will go beyond mere extraction and will overlap a great deal with front end cultivation and back-end product development. With these facts in mind, there are four major factors that are involved in cannabis processing: cultivation, analytics, […]
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FDA Takes Regulatory Action Against 21 Websites Selling Unapproved Opioids
FDA announced in August that it had warned four online networks operating 21 websites that they were illegally marketing dangerous, misbranded and unapproved opioids. One of them was tramadol. The FDA warning letters to each network stated that they must cease selling the products to consumers. According to FDA Commissioner Scott Gottlieb, selling opioids online […]
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FDA Plans to Revisit PMTA Process in 2018 and 2019
Approximately one year after it announced a tobacco strategy that features nicotine levels in regular cigarettes and other similar measures to cut tobacco use, FDA stated that it intended to take another look at the process it uses to evaluate new products containing tobacco, as well as how the agency approves them for sale and […]
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FDA’a Regulatory Dilemma on e-Cigarettes
Many experts in the FDA regulatory industry say that FDA has a serious regulatory issue on its hands with e-cigarettes. In a sense, the US government may want to encourage people to use e-cigarettes; if e-cigs were to replace cigarettes entirely, it is certain that this would save lives and billions of dollars in medical […]
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Sun Pharma Plant in India Hit with FDA 483
FDA inspectors in early September 2018 spotted several GMP issues at Sun Pharm’s manufacturing facility in Halol, Gujarat, India. This OAI inspection result put the drug manufacturing facility back in the spotlight after it got the green light from FDA in 2017. The pre-approval inspection noted six GMP related problems, including issues with the plant’s […]
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