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Regulatory Affairs

This article provides an overview of the prescription to non-prescription switch process in Canada. The author examines factors to be considered in determining drug scheduling and provides an overview of the prescription to non-prescription process at both the federal and provincial/territorial levels, highlighting the often-complex details of the switch with illustrative examples of recent switches.

Posted: February 20, 2018, 8:47 pm
Sarepta Therapeutics, Merck, Illumina and industry group PhRMA have offered their support and suggested changes for US Food and Drug Administration (FDA) draft guidance to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases.
Posted: February 20, 2018, 8:02 pm
Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.
Posted: February 20, 2018, 7:05 pm
The US Food and Drug Administration (FDA) last week warned Taiwanese firm Pacific Hospital Supply Co for failing to meet good manufacturing practice (GMP) standards.
Posted: February 20, 2018, 6:38 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: February 20, 2018, 4:57 pm

Biotechnology

INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
Posted: February 20, 2018, 12:00 am
Avillion is focused on this collaborative approach to advancing the development of late-stage clinical candidates for pharmaceutical company partners.
Posted: February 16, 2018, 12:00 am
Shares of Pacira plunged more than 15 percent this morning after the company revealed the FDA panel's decision.
Posted: February 16, 2018, 12:00 am
The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form.
Posted: February 16, 2018, 12:00 am
The meeting is tentatively scheduled for May 10, 2018. Volanesorsen is an investigational therapy for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS).
Posted: February 16, 2018, 12:00 am

Pharmaceuticals

The bar for clinical trials involving children, by design, is set higher than it is for adults. That does not mean the outcomes will be any better, according to a…
Author: Elizabeth Cooney
Posted: February 20, 2018, 7:00 pm
The chips hold human cells and blood so scientists can test medicines on tissues that are unique to different organs.
Author: Jonathan Saltzman — Boston Globe
Posted: February 20, 2018, 6:38 pm
Kratom, a drug the FDA recently said it considered an opioid, is now to blame for salmonella infections across the U.S.
Author: Helen Branswell
Posted: February 20, 2018, 5:38 pm
DNA testing won’t guide dieters to the weight-loss regimen most likely to work for them, scientists reported in a new study.
Author: Sharon Begley
Posted: February 20, 2018, 4:00 pm
Acupuncture is increasingly being embraced by patients and doctors, sometimes as an alternative to the powerful painkillers behind the nation's opioid crisis.
Author: Associated Press
Posted: February 20, 2018, 3:05 pm

Human Resources

The talent problem in STEM, in particular, has forced government leaders, educators and company executives to come together to find solutions.

Posted: February 20, 2018, 7:50 pm

Employees are the first line of defense when it comes to breaches, and training needs to reflect that.

Posted: February 20, 2018, 7:15 pm

Skillful State Network, endorsed by a bipartisan group of governors, aims primarily to help workers without a college degree transfer their skills to new ventures.

Posted: February 20, 2018, 7:05 pm

Development can be a sound investment. But unless it's coupled with a path for advancement, you're training your competitor's employees.

Posted: February 20, 2018, 6:35 pm

Some businesses say they're struggling to find workers who can pass a drug test, further exacerbating the skills gap.

Posted: February 20, 2018, 3:44 pm