OPDP slams print ad in Untitled Letter
The FDA’s prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom “misleadingly overstated its efficacy.”
Warning Letter
Pacira gets OPDP opioid promotion Warning Letter
The FDA’s Office of Prescription Drug Promotion says Pacira’s promotional materials for Exparel are “extremely concerning,” but the drugmaker tells investors the fuss is probably because opioids have been getting a lot of attention lately.
FYI: FDA habla español
The FDA issued a Warning Letter over unapproved drug claims published in Spanish.
Vet drugmakers get Warning Letters too
Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.
“Likes” put Zarbee’s in FDA crosshairs
The FDA says the OTC remedy maker’s online behavior—including Liking customer Facebook posts—has put the company’s drugs in unapproved drug territory.
EMA publishes noncompliance letters
The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.
FDA slams 23andMe over genetic testing device
Regulators say the company has not received approval for the device’s touted functions.
Researcher finds black-box drugs have high Warning Letter risk
EyeonFDA finds that, when it comes to black-boxed drugs’ marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
Merz web-copy shortcuts don’t sit well with OPDP
FDA’s Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
Business briefs: GlaxoSmithKline and Spectrum
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
