Posts Tagged ‘FDA’
Reauthorization of Generic Drug User Fee Seen As A Win For Consumers
Starting in 2012, the Generic Drug User Fee Amendments helped increase the number of generic drug applications approved by the FDA. Having recently been reauthorized, the FDA looks forward to increasing the number of safe and affordable generic drugs available to American citizens…
[...]Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication – FDA Warns Against Use
This is a reprint of an FDA Alert. [Posted 11/14/2017] AUDIENCE: Patient, Plastic Surgery, Dermatology, Surgery ISSUE: The FDA is alerting the public and health care providers that injectable silicone is not approved to enhance or augment the body. Such use can lead to ongoing pain, infections, and serious injuries, such as scarring and permanent…
[...]Med-Fast Settles Civil Case Over Selling Reused Medications To Nursing Homes
Instead of destroying unused medications, Med-Fast Pharmacy in Pennsylvania recycled and resold them to nursing homes. The company recently reached a settlement with the Department of Justice and agreed to a $2.6M fine…
[...]Company and CEO Charged With Illegally Adding Scheduled Drugs To Supplements
A recently unsealed indictment brings 18 charges, including introducing misbranded drugs into interstate commerce & manufacturing and distributing controlled substances, against Hi-Tech Pharmaceuticals and its CEO Jared Wheat…
[...]Maryland Woman Sentenced For Illegally Injecting Clients With Industrial Grade Silicone
Kendra Westmoreland of Maryland received a two-year prison sentence after admitting that she lied to her clients for 15 years. She was not injecting them with medical grade silicone, which it is illegal because of potential health complications. It was actually industrial grade silicone…
[...]Doctor Sentenced To 40 Months For Distributing Unapproved Medicine
Dr. George Patino convicted and sentenced for conspiracy, distributing Human Growth Hormone (HGH) for unauthorized medical purposes, and smuggling. He brought non-FDA approved HGH over from Mexico to treat patients with it for unapproved medical purposes…
[...]FDA-OCI Investigation Leads To Guilty Pleas From Two Men Who Sold Fake Drugs To Americans
The owner and the manager of a company in India ran a scheme cold calling phone numbers in the U.S. and Canada hoping the person who picked up the phone would be interested in purchasing some of their counterfeit medications. Both pleaded guilty to conspiracy charges in federal court…
[...]Naturopathic Doctor Pleads Guilty to Using Misbranded Drug on Patients
A Port Angeles, WA area naturopathic physician pleaded guilty in federal court to one count of introducing misbranded drugs into interstate commerce. Richard Marschall prescribed human chorionic gonadotropin (HCG) to approximately 60 people for weight loss between February 2014 and February 2017.
[...]FDA Regulation Keeps Both our Food and Medicines Safe
When policymakers talk about drug importation, they often make comparisons to importation of food. “If we can import produce safely,” they say, “don’t tell me we can’t import medicine.”
The truth is that importing food safely is difficult. The stakes are even higher when we import medicine: no one expects lettuce to cure cancer . . .
[...]DOJ Cases Highlight the Dangers of Illegal Silicone Injections
Cosmetic procedures are increasingly common these days, but so are illegally run clinics that promise to improve a person’s appearance while endangering their clients’ lives for the sake of profit. Two recent cases highlight the continuing efforts of the United States Department of Justice (DOJ) and the United Stated Food and Drug Administration (FDA) to…
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