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FDA
FDA Sends Warning Letter to Duchesnay Inc. Over Social Media Posts From Kim…
The Food and Drug Administration (FDA) has evidently been keeping a close eye on Kim Kardashian’s social media pages.…
Amarin Wins Preliminary Injunction Against FDA To Promote Truthful…
On Friday, a New York Federal Judge ruled that Amarin Pharma is allowed to promote Vascepa, the company's Omega 3…
FDA: “More Collaboration, Research Needed to Develop Cures”
The Food and Drug Administration's Deputy Commissioner for Medical Products and Tobacco, Robert Califf, recently offered…
FDA Communication Regulations Hurt Competition
We previously reported on Amarin’s lawsuit against the FDA, arguing that its restrictive interpretations of off-label speech would…
PatientsLikeMe Teams With FDA To Explore Patient-Reported Adverse Events
During last month's DIA Annual meeting in Washington, D.C., online patient community PatientsLikeMe announced a research…
OIG Continues Fight Against Medicare Part D Fraud and Abuse With Two New…
Last week, the Department of Health and Human Services announced the largest ever Medicare Fraud Strike Force sweep, with charges…
Safe For Blind People, Not Safe For Others? Public Citizen Criticizes…
Consumer watchdog group Public Citizen is criticizing the U.S. Food and Drug Administration’s decision to expand the approved use…
FDA Enforcement Update From CDRH, CDER, and CBER: Advertising and Promotion
Keeping track of the Food and Drug Administration’s enforcement of advertising and promotion of drugs, devices, and biologics is a…
NIH Halts Drug Making Operations after FDA Inspection
Today, the National Institutes of Health (NIH) was ordered to halt drug making operations after a fungal contamination…
Biosimilars: Abbvie Finds Fault with Zarxio Label, Submits Citizen Petition
On June 2, AbbVie, Inc. submitted a citizen petition requesting that FDA require the approved prescription drug labeling…