California compliance law
This article was originally published in The Gray Sheet
Executive Summary
Assemblywoman Lois Wolk (D-Davis) drops efforts to obtain legal council opinion regarding the applicability of SB 1765 to device makers and will wait to see how the law is implemented (1"The Gray Sheet" April 25, 2005, p. 3). The law, signed in September 2004, requires adoption of compliance programs in accordance with PhRMA and OIG guidelines, beginning July 1. However, "some [device] companies are looking at this and saying that with the provision of substantial compliance and with proper documentation...you could potentially follow the AdvaMed code," AdvaMed Exec VP Blair Childs stated at the association's Emerging Growth Company Conference June 9 in Minneapolis...
You may also be interested in...
CDRH FY 2006 Budget Authority Would Be $165 Mil., With $56 Mil. For Field
FDA enforcement activity will receive 70% of the $6 mil. increase President Bush is requesting for the medical device program in fiscal 2006
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.