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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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FDA Makes Clarifications About Making Inspection Results More Visible to Public

In early September 2018, FDA published new information about how it chooses and schedules drug manufacturing plant inspections all over the world, and the process that it uses to release the findings of those actions. FDA states that the more international nature of the pharmaceutical supply chain is making the agency revise how it does [...]

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FDA Provides Update on Risk-Based Drug Inspections

FDA announced in early September 2018 that it had released CDER’s Manual of Policy and Procedures or MAPP, called Understanding CDER’s Risk Based Side Selection Model. FDA provided some clarification of how it is prioritizing routine pharmaceutical manufacturer inspections. However, it failed to give any information on how predictable FDA inspections will be, or did it [...]

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Regulatory Oversight in Drug Compounding on the Rise

Drug compounding until very recently has had a lot looser regulation than that of pharmaceutical drugs. The looser regulations served a real function: It allowed people who need a very specific drug formulation that was not available in a widely manufactured product. This could include discontinued drugs or specific forms of current drugs that do [...]

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