Friday, December 28, 2018

FDA releases statement underlining their powers to manage a selection of cannabis products

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Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov


"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 
Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

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Tuesday, December 25, 2018

As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

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Read the full article:   As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

"Although most of the agency's employees weren't working over the weekend and on Monday and Tuesday because of federal holidays, FDA will furlough some 40 percent of its staff starting Wednesday. 
However, much of the agency's workforce will continue through the shutdown, with more than 10,000 FDA employees — nearly 60 percent — reporting to work, according to numbers released by the agency Friday."

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Thursday, December 20, 2018

Data Integrity and Compliance With Drug CGMP Questions and Answers - FDA.gov

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Read the entire FDA guidance (pdf):  Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry - FDA.gov

"In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FD&C Act regarding safety, identity, strength, quality, and purity. Requirements with respect to data integrity in parts 211 and 212 include, among other things: . . . "

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