May 20, 2022
May 20, 2022
September 20, 2018
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
June 20, 2022
JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...
April 18, 2022
FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs),...