New Prescription Drug Labeling
The new FDA rule will require more information about a drug’s effect on pregnant and nursing women. A rule affecting prescription drug and biological product labels will go ...
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 ...
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 ...
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 ...
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 ...
Testosterone Risks: FDA Requires New Warning Label
The FDA now requires a warning label to inform the public of a possible increase of heart attack and stroke in prescription testosterone users. New FDA Warning Label On March ...
Possible Zofran Link to Birth Defects
Use of Zofran in the first trimester of pregnancy has now been linked to birth defects. What is Zofran? Zofran is a drug that the FDA approved to prevent nausea and vomiting ...
Pradaxa Lawsuit
Newly Released Pradaxa Documents Show Employees Concern Pradaxa, a popular blood thinning medication, has been under fire recently. Though Pradaxa is a popular drug, it ...
FDA Calls Committee Meeting to Assess Dangers of Testosterone
The United States Food and Drug Administration (FDA) announced that it will convene a joint meeting to assess the cardiovascular risk associated with testosterone replacement ...
Benicar Linked to Severe Gastric Problems
Benicar is one of the leading blood pressure medications on the market today. Today, doctors write over 11 million prescriptions for patient per year. Benicar’s active ...