FDA and DEA send joint warning letters to illegal opioid sites

European Pharmaceutical Review | October 03, 2019

FDA and DEA send joint warning letters to illegal opioid sites
The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products. The US Food and Drug Administration (FDA) has issued warning letters to four online networks which were illegally marketing unapproved and misbranded versions of opioid medicines. The cautions were sent as joint with the Drug Enforcement Administration (DEA). A total of 10 websites were found to be within the networks, which also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies. The sites have been told they must cease selling the opioids, including unapproved tramadol, immediately.

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The Health Risk Assessment (HRA) is a beneficial first step in laying the foundation of a good employee wellness the program, a personalized prevention plan, or population health management. A well-designed HRA helps individuals get a good picture of their health status and future quality of life by making the connection between lifestyle habits and the risk for chronic disease.

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RESEARCH

Pfizer, Moderna urge calm as they launch tests of vaccines against mutated COVID-19

Pfizer | December 29, 2020

After a changed, quick spreading variation of COVID-19 in the U.K. disturbed worldwide travel throughout the end of the week, an upsetting inquiry arose: Will the new antibodies from Pfizer and Moderna neutralize this startling new strain of the infection? Presently the two organizations, alongside Pfizer's COVID-19 accomplice BioNTech, are racing to quiet an apprehensive public. They're dispatching new investigations intended to demonstrate their mRNA-based shots will fight off the new Covid strain, while at the same time communicating certainty this new antibody innovation is ideal for ensuring against quickly changing infections. Pfizer and BioNTech have tried their antibody "for its capacity to kill various freak strains. Until now, we have discovered steady inclusion of the multitude of strains tried," they said in an assertion. The organizations are currently gathering information from individuals who have gotten the shot to decide how well they "might have the option to kill the new strain from the U.K.," Pfizer added. Moderna didn't promptly react to a solicitation for input yet said in an assertion gave to other news sources that it expects "that the Moderna immunization instigated insusceptibility would be defensive against the variations as of late portrayed in the U.K.," and that it "will play out extra tests in the coming a long time to affirm this desire." Pfizer brought up that when SARS-CoV-2, the infection that causes COVID-19, first arose a year prior, it was clear there was more than one strain of it, and that it was transforming as it spread. SARS-CoV-2 is a RNA infection, and all things considered, it has "astoundingly high [mutation] rates" on the grounds that the chemicals it utilizes for replication are "inclined to mistakes when making new infection duplicates," the organization said. "One reason Pfizer and BioNTech decided to use a mRNA stage is a direct result of the potential for the adaptability of the innovation in contrast with customary immunization advancements," including the capacity to change the RNA arrangement in the antibody, should a strain arise that is not covered by the current shot," Pfizer added.

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Parallel's Surterra Wellness Stores to Introduce New Products Including Edibles in Florida

Prnewswire | August 31, 2020

Parallel, formerly known nationally as Surterra Holdings, a company pioneering well-being through its proprietary cannabinoid brands, science and technology-led innovation, today announced that it will introduce new edible cannabis products to its customers in its 39 Florida Surterra Wellness stores. This expansion of Surterra Wellness' product offering follows the Florida Department of Health's (FDOH) finalizing recently released emergency rules to allow for the production and sale of edible products. Launch is dependent on regulatory approval of each of those products. Surterra Wellness, widely known for its line of whole flower, vaporizers, tincture oils, topical patches, theragels and lotions, is Parallel's leading cannabis retail brand for patients and customers aiming to improve their well-being in both Florida and Texas.

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Thermo Fisher Scientific Launches Modular Closed Cell Processing System for Cell Therapy Manufacturing

Thermo Fisher | October 15, 2020

Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing. As of mid-2020, 675 clinical trials were underway globally for cell therapy and cell-based immune-oncology, according to the Alliance for Regenerative Medicine. Yet few cell therapies in development become commercially available due to several factors: safety and efficacy requirements, difficulties in transferring research protocols to manufacturing processes, lack of scalability of these therapies, high cost of facilities, labor and equipment, and complexity of the processes involved.

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Spotlight

The Health Risk Assessment (HRA) is a beneficial first step in laying the foundation of a good employee wellness the program, a personalized prevention plan, or population health management. A well-designed HRA helps individuals get a good picture of their health status and future quality of life by making the connection between lifestyle habits and the risk for chronic disease.