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...
FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...
Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nordisks and Lillys GLP-...
Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybrid Pharma became rev...
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.