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13 May 2024, 5:58 pm by Kurt R. Karst
Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert —FDA has long touted the use of real-world evidence (RWE). [read post]
22 Mar 2024, 4:00 am by Guest Blogger
” This continues the sordid state of affairs that existed prior to the pandemic, where hundreds of criminal cases were being dismissed annually for delay[9]. [read post]
6 Mar 2024, 9:03 pm by renholding
[5] Commission Guidance Regarding Disclosure Related to Climate Change, Release No. 33-9106 (Feb. 2, 2010) [75 FR 6290 (Feb. 8, 2010)] [6] See Basic Inc. v. [read post]
11 Dec 2023, 8:33 pm by Kurt R. Karst
”[16]  However, the experience of the New York State Department of Health (NYSDOH) should serve as a cautionary tale. [read post]
1 Nov 2023, 9:41 pm by Kurt R. Karst
Gibbs —For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here). [read post]
12 Oct 2023, 6:30 am by Guest Blogger
Frederick (2007) and Holder v. [read post]
8 May 2023, 12:28 am by Christin Thompson
States also have the administrative authority to bar providers from participating in their State Medical Assistance Programs (primarily Medicaid and CHIP).[5] Medicaid exclusion actions[6] are similar to OIG exclusions in many respects, but there are also important differences. [read post]
13 Dec 2022, 6:52 pm by Kurt R. Karst
  FDA has in fact asserted this position in the past: CRL v. [read post]
12 Dec 2022, 7:23 am by INFORRM
On Wednesday 7 December 2022, there was a hearing in the case of Schlumberger v Gibbs and another (QB-2019-004261). [read post]
5 Dec 2022, 12:49 am by INFORRM
” This is despite China’s National Intelligence Law which requires citizens to cooperate and assist with state intelligence work. [read post]
10 Nov 2022, 3:03 pm by Kimberly A. Kralowec
" The speakers are Andre Mura of Gibbs Law Group LLP; Zoe Savitsky of the Oakland City Attorney's Office; Steven E. [read post]