Legal Advice for FDA — 22 results
Written by attorney Brett Emison, over 4 years ago.
Two new studies -- one published in the Journal of the American Medical Association (JAMA) and another published in the Archives of Internal Medicine -- showed that diabetes drug Avandia... more
Written by attorney Peter Quinter, almost 5 years ago.
Identify legal and factual bases for the warning letter. You must be very familiar with the laws and regulations of the FDA, as well as the FDA's policies and practices for a particular... more
Written by attorney Robert Greiwe, over 1 year ago.
The United States Food and Drug Administration notified healthcare professionals last Friday, February 22, 2013, that it was issuing a Class I recall of the LPS Diaphyseal Sleeve. The... more
Written by attorney R. Bomberger, about 2 years ago.
Until the first transvaginal mesh device was released in 1996, pelvic organ prolapse (POP) and stress urinary incontinence (SUI) were treated through surgery, sewing and reinforcing the... more
Written by attorney Daniel Buttafuoco, about 3 years ago.
Washington, DC By Lucy Campbell: A post-marketing report released in October by the Food and Drug Administration (FDA) on the safety of new generation contraceptives reportedly states that... more
Written by attorney Christopher Zachar, about 3 years ago.
The U.S. Food and Drug Administration (FDA) recently launched a brand-new Web site to make it easier for consumers to find out about and track recalled products.
About 3,000 Americans... more
Written by attorney John A Dalimonte, over 3 years ago.
On August 9, 2010, the FDA issued a communication concerning problems
with Bards Inferior Vena Cava filters or IVC filters. Since that time,
IVC filter lawyers continue to be called... more
Written by attorney Daniel Buttafuoco, almost 4 years ago.
March 1, 2011. By Heidi TurnerWashington, DC: Following the DePuy hip replacement recall, the US Food and Drug Administration (FDA) announced it is
investigating concerns about metal-on-... more
Written by attorney Scott Hendler, about 4 years ago.
Despite earlier requirements for warnings, labels on
gadolinium-based contrast agents (GBCAs) must now include even more
stringent warnings, according to the September 9 ruling... more
Written by attorney Gerald Abdalla, 8 months ago.
The Food and Drug Administration is proposing strict new safety requirements for plastic mesh implants used to repair women’s pelvic problems — years after the agency concluded that the... more