FDA warning letter
FDA warns J&J’s Abiomed over quality issues with Impella heart pumps and software
Anika Sharma
The FDA has taken significant steps in its response to safety concerns surrounding certain Abiomed heart pumps. Following several Class ...
FDA Issues Warning Letter to AstraZeneca Regarding ‘Misleading’ Breztri Efficacy Claims
Anika Sharma
AstraZeneca’s promotional campaign for Breztri Aerosphere, a treatment for chronic obstructive pulmonary disease (COPD), has encountered significant regulatory turbulence, with ...
