C. Calvin Warriner III on Food and Drug Administration (FDA)

Greatbatch Medical Recalls Hip-Replacement Instrument Which Has Potential To Infect Patients

The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests....more

5/2/2017 / Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Product Defects , Product Recalls

Anaphylaxis Possible Risk of Recalled EpiPen Auto-Injector, Epi-Pen Jr Auto-Injector

A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need....more

4/14/2017 / Food Allergies , Food and Drug Administration (FDA) , Medical Devices , Mylan Pharmaceuticals , Pharmaceutical Industry , Product Defects , Product Recalls

Taper Failures – A Hot Topic in Orthopedics

After a decade of receiving several black eyes over failed metal on metal implants, the orthopedic device industry is bracing itself for a second wave of metal failure related embarrassment. The metal on metal debacle...more

10/4/2016 / Food and Drug Administration (FDA) , Healthcare , Medical Devices , Pharmaceutical Industry , Product Defects

Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’

Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration has the responsibility to...more

7/12/2016 / Acceleration , Clinical Trials , Food and Drug Administration (FDA) , Pharmaceutical Industry , Premarket Approval Applications , Prescription Drugs

Questions About FDA’s Drug Approval Process Answered

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to...more

5/27/2016 / Drug Testing , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Amarin Pharma Comes Out on Top in Federal Case Involving Freedom of Speech

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more

5/16/2016 / Amarin , First Amendment , Food and Drug Administration (FDA) , Free Speech , Off-Label Promotion , Pharmaceutical Industry , Prescription Drugs

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

4/19/2016 / Adverse Events , Drug Safety , Food and Drug Administration (FDA) , Gilead Sciences , GlaxoSmithKline , Manufacturers , Pharmaceutical Industry , Prescription Drugs , Reporting Requirements , Side Effects , Warning Labels

FDA Should Address Adverse Impacts of Artificial Food Coloring

Grocery store shelves are filled with foods that contain artificial coloring. Breakfast cereal. Cake frosting. Candy bars. Drink mixes. Up and down the aisles, Blue 2, Red 40, Yellow 5 and other chemical combinations lurk on...more

1/26/2016 / Children's Products , Food and Drug Administration (FDA) , Food Labeling , Food Safety

FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits...more

11/18/2015 / Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Urges Healthcare Professionals To Consider Alternatives to Power Morcellation

The scrutiny that has arisen within the healthcare community over hysterectomies performed by laparoscopic power morcellation has the Food and Drug Administration (“FDA”) thinking twice about the safety of the procedure....more

7/15/2014 / Food and Drug Administration (FDA) , Healthcare

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

6/24/2014 / Department of Justice (DOJ) , Food and Drug Administration (FDA) , Healthcare , Hospitals , Humana , Insurance Industry , Medical Devices , Medtronic , Off-Label Promotion , Off-Label Use , Physicians , Popular , RICO

FDA: Seafood Will Not Have Labels for Mercury

Imagine shopping for seafood at a fish counter and seeing a display on the mercury levels contained within the varieties of fish sold. In an ideal world, that disclosure would be transparent for pregnant women and for all...more

6/17/2014 / Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , Food Labeling , Mercury , Seafood

Shouldn’t A Permanent Medical Device Implant Be Considered High-Risk?

It really doesn’t sound like a question we need to be asking because it should be a matter of common sense. Shouldn’t any medical device that is permanently implanted in the human body be put through a high degree of...more

5/21/2014 / Food and Drug Administration (FDA) , Health and Safety , Medical Devices , Public Comment , Transvaginal Mesh

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

5/13/2014 / Clinical Trials , EU , Food and Drug Administration (FDA) , Marketing , Medical Research , Off-Label Use , Pharmaceutical Industry , Prescription Drugs

FDA: Proposal to Call Pelvic Mesh High-Risk, Require Testing

A major move toward public safety may be one step closer with the U.S. Food and Drug Administration announcing this week that it will put a proposal out for public comment that would reclassify pelvic organ prolapse (POP)...more

5/2/2014 / Bodily Injury , Food and Drug Administration (FDA) , Medical Devices , Transvaginal Mesh

FDA Reports Rise in Medical Device Recalls and Warnings

This news is not surprising to anyone who pays attention to medical device recalls. There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division...more

4/9/2014 / Food and Drug Administration (FDA) , Medical Devices , Product Recalls

Living off the Label

Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more

3/24/2014 / Food and Drug Administration (FDA) , Labeling , Off-Label Use , Pharmaceutical Industry , Prescription Drugs

DePuy Wants to Slip Away From Metal Hip Jury Verdict

Johnson & Johnson (J&J) has requested that an $8.3 million judgment against the company over its DePuy metal-on-metal (MoM) hip implant be put on hold....more

5/7/2013 / DePuy Hip Replacement , Design Defects , Food and Drug Administration (FDA) , Hip Replacement , Johnson & Johnson

C. Calvin Warriner III

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