Topic: regulatory affairs
Thursday, February 21, 2019
This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development and how to save time and money while maximizing the value of their drug development program.
The flag lowering took place as the European Medicines Agency “symbolically said goodbye” to the city it has called home since its creation in 1995.
Staff at the office will create tools that sponsors and the FDA can use to streamline the development and regulatory assessment of drugs.
A political deadlock that led to a partial government shutdown before Christmas could take some of the shine off a golden year of FDA approvals.
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.