by Katrina Rogers | Sep 6, 2018 | Uncategorized
The announcement this week that Jack Stoddard will be the COO of the yet to be cleverly named new health venture created by Amazon, Berkshire Hathaway and J.P. Morgan should clarify for my readers that digital health will be the next big thing. In addition to being...
by Katrina Rogers | Sep 4, 2018 | Uncategorized
What is it, and what has been done? In late July the FDA celebrated the one-year anniversary of the Digital Health Innovation Action Plan. This initiative (run by the Center for Devices and Radiological Health) is focused on improving and streamlining the agency’s...
by Katrina Rogers | Sep 2, 2018 | Uncategorized
Announcement this week of the recall of a batch of blood pressure medication from Accord Healthcare Inc (read the recall notice here) reminds us why Labeling and Packaging is one of the 6 critical GMP systems. The drug product (hydrochlorothiazide HCl, a commonly used...
by Katrina Rogers | Aug 30, 2018 | Uncategorized
On August 23rd, the FDA posted a request for nomination of individuals willing to serve on the public advisory committees for Device Good Manufacturing Practice and Medical Device subtypes. The agency seeks the help of technically qualified scientific and clinical...
by Katrina Rogers | Aug 28, 2018 | Uncategorized
The Center for Devices and Radiological Health (CDRH) is now accepting applications from medical device companies, academia, and healthcare companies to host a site visit for CDRH reviewers (both new and experienced) to help them better understand patient needs and...
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