Generic Drug Labeling: Explaining PLIVA, INC v. Mensing
Recently, there has been a lot of talk about proposed changes to federal laws that govern generic drug labeling. The Food and Drug Administration has proposed a law that would ...
Powdered Alcohol Gains Approval, But Also Bans
Last month, the Alcohol and Tobacco Tax and Trade Bureau approved labels for Palcohol, which allows the product to be sold in the United States. Palcohol is a powdered alcohol ...
FDA Unkind to KIND Bars
Go to your local grocery store and you will likely find KIND bars in the health food section. KIND has marketed their bars as being a great health-food snack for consumers. ...
Common Herbicide Labeled “Probable Carcinogen” by WHO
In late March, the International Agency for Research on Cancer, the France-based cancer research arm of the World Health Organization (WHO), labeled the weed-killer RoundUp a ...
FDA Holds Hearing on Proposed Generic Drug Rule
March 27, 2015: The FDA held a public meeting regarding its November 2013 proposed rule that would allow generic-drug manufacturers to update their product labels for safety ...
FDA Now Investigating Birth Control Device Essure
The Food and Drug Administration (FDA) announced that it will launch an investigation into the safety of the birth control device Essure. The FDA’s decision comes after ...
FAQs: Pharmaceutical and Medical Device Cases
When considering whether to pursue a lawsuit in a pharmaceutical or medical device case, there are many questions that arise. Pharmaceutical and medical device lawyer Sara ...
Maryland’s False Claims Act Doesn’t Go Far Enough
Last week, the Maryland Senate passed legislation amending Maryland’s False Claims Act. While the bill passed with nearly a unanimous vote of 46-1, Maryland’s False Claims Act ...
Celiac Sufferer Sues FDA to Remove Gluten from Drugs
On March 16, 2015, a New York man filed suit in U.S. District Court for the District of Columbia asking a judge order the Food and Drug Administration (FDA) to remove gluten ...
SEC Whistleblower Program
Although relatively new, the Securities and Exchange Commission (SEC) whistleblower program and its implementation have shown a strong commitment to investigating financial ...
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