AGA Amplatzer Pivotal Study Investigator Draws FDA Warning Letter
This article was originally published in The Gray Sheet
A principal investigator in AGA Medical's Amplatzer septal occluder pivotal study, currently under PMA review, was cited in an FDA warning letter for failure to properly report issues of informed consent, patient follow-up and compassionate use of the device
You may also be interested in...
Spine-Tech unit President Dennis Wallach also will lead the Cardiovascular Prostheses unit following the departure of its leader Terry Marlatt, announced Dec. 4. Wallach had replaced Paul Lunsford at Spine-Tech on Oct. 17 when Lunsford left to become president and CEO of Acorn Cardiovascular (1"The Gray Sheet" Oct. 29, 2001, p. 8). Merging the management of the two Sulzer units will help reduce costs, the firm says. Separately, John Calhoun Wells has been hired by Sulzer and plaintiffs as a mediator to help settle ongoing hip and knee recall cases. Wells was named by the Cleveland federal district court under a Nov. 29 agreement by the two sides in order to prevent the company from being forced into Chapter 11 by suits outside its $783 mil. proposed settlement (2"The Gray Sheet" Dec. 3, 2001, p. 20)...
FDA approval of AGA Medical's Amplatzer septal occluder should include a requirement for a five-year postmarket study of patients under 10 years of age who receive the device, the agency's Circulatory System Devices Panel recommended at its Sept. 10 meeting in Gaithersburg, Maryland.
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.