Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certain drugs over the cou...
A law firm examines FDAs renewed scrutiny of direct-to-consumer television advertising after issuing seven untitled letters so far in 2026.
Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warning that continued use without updated instructions...
As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to change medical device o...
PTC Therapeutics withdraws its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, following feedback f...
A new academic paper urges FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that moving too fast to tran...
A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramatically expand disclos...
FDA approves labeling changes removing some Boxed Warnings from six hormone replacement therapy products.
