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The Definition of “Fully Vaccinated” Needs to Change

Eye on FDA

Today CDC provided important insight into the ability of the new variant to make headway with a highly vulnerable population when it released data on infections in the nursing home environment. It would seem that Omicron has rendered that definition outmoded. We even have a pile of misinformation.

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Improving clinical trials through patient experience

Drug Discovery World

million seed funding to create the definitive patient retention platform for clinical trials. User research was also undertaken with research nurses at members of the Experimental Cancer Medicines Centres network to get the perspectives of those working in research. MT: Near the end of 2022, Stitch closed £2.5

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Mother of 4-Year-Old Living With KAND, One of the Rarest Disorders in the World, Advocates to Find a Cure

KIF1A

We sold our house, I gave up my career as a nurse, and we moved to Calgary. I definitely do believe she understands that Emma’s different,” Amanda continues. “I immediately started researching where in Canada has the best resources for Emma. Where’s the best therapy? Where’s the best schools? Amanda says. “We

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Article FDA Thank You FDA drafts ‘select updates’ to guidance on medical device cybersecurity, addressing statutory requirements

Agency IQ

Today, the agency published a draft version of those “select updates,” which delineate how the FDA will interpret key statutory definitions and provide expectations for documentation and for bringing existing devices into compliance. The law gives some specific requirements as to what types of information are required for “cyber devices.”

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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

In 2001, the FDA issued a guidance to “alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.” Within the 2017 omnibus funding bill, lawmakers made a more definitive request to the FDA to issue final regulations on medical gases.

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Article FDA Thank You FDA gives companies leeway to go after misinformation, but not free reign

Agency IQ

The up-front glossary in the new guidance also provides standard definitions related to a product’s approved use, an “unapproved use” (i.e., Online information may or may not fit the definition of misinformation that can be responded to under this enforcement discretion. something not in the labeling), labeling and medical product.

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Health Officials Work to Speed Up U.S. COVID Vaccine Rollout

The Pharma Data

million, will boost its vaccine rollout to now include health care workers, nursing home residents and staff, as well as those living in congregate settings such as assisted living or shelters. Health officials had hoped to get 20 million people vaccinated by Jan. 1, but the national rollout has faced delays and roadblocks.

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