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 ...
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 ...
Takata Airbags: Death & Injury Toll Mounting
Six people have died and at least 160 have been injured due to defective Takata airbags, marking one of the most serious and notable automobile product defects in existence ...
Duodenoscope Procedures: Things to Consider
Last Thursday, the FDA issued a warning letter concerning the design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes. What is an Endoscopic Retrograde ...
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 ...