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FDA Doubts McKesson’s Abilities to Detect Illegitimate Drug Products

The US Food and Drug Administration (FDA) recently posted a Form 483 sent in July to the nation’s largest drug distributor, McKesson, and questioned the firm on how it detects illegitimate products. The release of the Form 483 follows an investigation last year from the Washington Post and 60 Minutes highlighting McKesson’s failure to report suspicious orders involving millions of [...]

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How to Fail an FDA Medical Device Inspection in 3 Easy Steps!

Have you ever thought about what the most common issues are in an FDA 483 for medical device manufacturers? The Medical Device Academy recently analyzed FDA 483s from 2013, and the research found that the most common observations were regarding design controls, CAPAs, and complaint handling. Design control problems were in 13.25% of all FDA [...]

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What You Should Expect in GMP Quality Agreements

Have you wondered what the responsibility of your drug company is when it comes to the assurance of GMP quality and safety of products and ingredients that are made at your contract facility? It should be remembered that while the drug company has the ultimate responsibility for caregivers and patients to meet quality and safety expectations, [...]

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Don’t Be Haunted By Your Words in Documents

Association of Food and Drug Officials Don’t Be Haunted By Your Words! By Nancy Singer and Joseph Pickett In this article, Ms. Singer and Mr. Pickett offer advice to both government and industry officials on writing clear and concise reports that won’t come back to haunt them in the future. How to Avoid Mistakes in [...]

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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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