The OPDP has only issued two letters in 2017, compared to 11 last year.
The FDA warns drugmaker over opioid promotion; Watson may not be living up to the hype; Merck acquires immuno-oncology biotech
Gilead to acquire Kite; the FDA issues fewest number of warning letters since 2008; the regulator approves BI's Humira biosimilar
The regulator also took issue with how Orexigen Therapeutics presented the risk information
GSK warns Advair generic competition may affect business in 2017; Lilly plans to meet FDA about baricitinib; FDA warns companies selling 'illegal' products
It's hard to be against the concept of reform, but Trump is better known for epithets than policy details, Kamp writes.
The agency issued 11 enforcement letters last year.
Our editorial staff contemplates what 2017 has in store for healthcare marketers, and we forsee big changes and some setbacks in the ongoing shift toward a data-driven, value-based industry.
Biogen names new CEO; the FDA issues two warning letters; Allergan to acquire aesthetics firm
The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.
Vertex drug challenged by low refill rates; the FDA has issued only 4 warning or untitled letters this year; Horizon settles PBM-rebate suit
The drugmaker marketed a co-pay assistance voucher that failed to provide any risk information about its drug Ulesfia.
It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.
The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.
An analysis conducted by J&J executives found that 58% of FDA warning letters and untitled letters over the last two years omitted risk information.
Amgen's PCSK9 inhibitor is the second in its class to get an FDA panel endorsement; a new drug could threaten Shire's hold on a rare-disease category; a study shows pharma invests less in Hispanic audiences than in other groups
A House committee is looking into the FDA's warning letter publication process; Amgen and Roche collaborate on cancer combination drug; study shows online health information fails teenagers
President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.
The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."
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.
The FDA issued a Warning Letter over unapproved drug claims published in Spanish.
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.
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.
The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.
Regulators say the company has not received approval for the device's touted functions.
EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.
FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
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.
The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.
FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.