Important Fireworks and Sun Safety Tips for a Safe and Happy July 4th

Independence Day is right around the corner, and that means good food, fun in the sun and, of … [Continue Reading]

Important Fireworks & Sun Safety Tips for July 4th

Hip Replacement Tools Recalled Over Manufacturing Residues That Can Cause Adverse Health Events

The U.S. Food and Drug Administration (FDA) on June 8 announced a Class I recall of certain Zimmer … [Continue Reading]

Hip Replacement Tools Recalled

Health Experts Fear the FDA’s Public Meeting Over Drug Companies’ Constitutional Rights Will be a Setback for Drug Safety

The U.S. Food and Drug Administration (FDA) will hold a public meeting this month to discuss whether … [Continue Reading]

Health Experts Fear the FDA’s Public Meeting Over Drug Companies’

Pharmacies Granted Additional Time to Comply with New Track and Trace Requirements for Shipments

The Food and Drug Administration (FDA) has given pharmacies an additional four months to comply with … [Continue Reading]

Pharmacies Given Time with New Track & Trace Requirements

After Pleading Guilty to Selling Adulterated Knee Implant Cutting Guides, Former OtisMed CEO Sentenced

According to the U.S. Food and Drug Administration (FDA), the former chief executive office of … [Continue Reading]

Former OtisMed CEO Sentenced After Pleading Guilty

Important Fireworks & Sun Safety Tips for July 4th

Important Fireworks and Sun Safety Tips for a Safe and Happy July 4th

Independence Day is right around the corner, and that means good food, fun in the sun and, of course, fireworks. But forgetting to guard against the sun and those potentially fireworks can land you in the hospital, or worse. According to the U.S. Consumer Product Safety Commission (CPSC), about 230 people wind up in the […]

Hip Replacement Tools Recalled

Hip Replacement Tools Recalled Over Manufacturing Residues That Can Cause Adverse Health Events

The U.S. Food and Drug Administration (FDA) on June 8 announced a Class I recall of certain Zimmer M/L Taper with Kinectiv ® Technology Femoral Stems and Necks due to an overabundance of manufacturing residues. A Class I recall indicates “a situation in which there is a reasonable probability that the use of or exposure to a […]

Health Experts Fear the FDA’s Public Meeting Over Drug Companies’

Health Experts Fear the FDA’s Public Meeting Over Drug Companies’ Constitutional Rights Will be a Setback for Drug Safety

The U.S. Food and Drug Administration (FDA) will hold a public meeting this month to discuss whether drug companies have a Constitutional right to make certain claims about their products. HealthNewsReview.org reports the agency will debate whether to allow drug manufacturers to bypass the review process for the totality of the available data, including secret […]

Pharmacies Given Time with New Track & Trace Requirements

Pharmacies Granted Additional Time to Comply with New Track and Trace Requirements for Shipments

The Food and Drug Administration (FDA) has given pharmacies an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA). The DSCSA was signed into law in 2013, containing extensive pharmaceutical compounding reform provisions and establishing a nationwide pharmaceutical “track and trace” system to deter […]

Former OtisMed CEO Sentenced After Pleading Guilty

After Pleading Guilty to Selling Adulterated Knee Implant Cutting Guides, Former OtisMed CEO Sentenced

According to the U.S. Food and Drug Administration (FDA), the former chief executive office of OtisMed Corporation, Charlie Chi, has been sentenced after pleading guilty to selling adulterated knee replacement cutting guides. Chi is to serve 24 months in prison, one year of supervised release and pay $75,000, the U.S. District Court of the District […]

Lawsuit Seeks FDA Release of Clinical Trial Data

Lawsuit Seeks FDA Release of Clinical Trial Data for Two Hepatitis C Drugs

The Food and Drug Administration (FDA) is being sued for the release of clinical trial data for two hepatitis C drugs made by Gilead Sciences. Treatment Action Group and the Global Health Justice Partnership have sued for release of patient-level trial data for Sovaldi (sofosbuvir) and Harvoni (ledipasvir), the Wall Street Journal reports. This is […]

DaVita Whistleblowers May be Awarded More than $110 Million

DaVita Whistleblowers May be Awarded More than $110 Million

An Atlanta doctor and nurse who exposed alleged fraud at DaVita Healthcare Partners, the largest dialysis provider in the country, may receive over $110 million for their whistleblowers. The company is accused of scheming to maximize federal reimbursements by wasting dialysis drugs. Prior to 2011, the federal government reimbursed for wasted dialysis medicine so long […]

FDA Order Phasing Out Trans Fats Could Lead to Litigation

FDA Order Phasing Out Trans Fats Could Lead to Spate of Litigation

In its order phasing out trans fats in the nation’s food supply, the Food and Drug Administration (FDA) may have opened the door to a spate of lawsuits over trans fats. In 2013, the FDA issued a preliminary determination that partially hydrogenated oils (PHOs) will no longer be considered “generally recognized as safe” (GRAS). That […]

Higher-Than-Expected Revision Rates

U.K. Health Regulator: Higher-Than-Expected Revision Rates in Some Patients Implanted with Smith & Nephew Hip Device

The Medicines and Healthcare Products Regulatory Agency (MHPRA) in the United Kingdom (U.K.) on June 25 issued a medical device alert  on the agency’s website concerning the Birmingham Hip Resurfacing™ system made by Smith & Nephew Orthpaedics. The alert is intended for medical directors, orthopedic departments, orthopedic surgeons and staff involved in the management of […]

ADHD Drug Patch Linked to Permanent Skin Condition

ADHD Drug Patch Linked to Permanent Skin Condition

The U.S. Food and Drug Administration (FDA) is warning that use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD) may cause a skin condition known as chemical leukoderma, which can cause a permanent loss of skin color. The agency said in a June 24 Safety Announcement on its website that […]