Topic: regulatory affairs
An industry survey conducted by KPMG and RAPS found little familiarity with the EU’s new Medical Device Regulation, which will take full effect in May 2020.
The IMDRF is launching a new working group aimed at harmonizing regulatory principles surrounding device cybersecurity.
The latest Apple Watch includes an FDA-cleared ECG, making it a medical device capable of alerting users to abnormal heart rhythms.
Amicus must now continue adding to its existing phase 1/2 data with a view to sitting down again with the agency next year.
Officials reiterated their intent for the U.K. to implement the incoming EU Clinical Trials Regulation and expanded on the long-term effect of Brexit.
The EMA now expects to lose 30% of its workers, up from the 19% predicted by its staff survey.
Beijing’s CANbridge Life Sciences, developing Western drug candidates in China and Asia, brought on Pfizer’s May Orfali to be chief medical officer.
The FDA finalized an eagerly awaited guidance on incorporating EHRs and real-world data into clinical trials, including from foreign sites.
The voted-for text tasks the government with seeking to secure the right for the U.K. to “fully participate” in the EMA after Brexit.
Already knowing Theranos’ story doesn’t make "Bad Blood" a less interesting read but offers a rare connection to its players as the scandal unfolds.