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10 Oct 2023, 6:34 pm by Kurt R. Karst
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert —As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. [read post]
23 Sep 2023, 7:21 pm by Bill Marler
  For example, produce has been the source of substantial numbers of outbreak-related E. coli O157:H7 infections since at least 1991. [13, 24]  Outbreaks have been linked to alfalfa, clover and radish sprouts, lettuce, and spinach. [31, 32]Other vehicles for outbreaks include unpasteurized juices, yogurt, dried salami, mayonnaise, raw milk, game meats, hazelnuts, and raw cookie dough. [10, 13, 30]  NON-O157 STEC Non-O157 Shiga… [read post]
13 Sep 2023, 11:46 am by LII Team
Elenis, Students for Fair Admissions Inc. v. [read post]
5 Sep 2023, 9:53 am by Jennifer Lynch
Montana’s straightforward law went into effect two and a half years before California’s landmark privacy law, CalECPA, codified similar protections for location data—and five years before the Supreme Court, in Carpenter v. [read post]
4 Sep 2023, 9:02 am by Marcel Pemsel
This has caused inflation, necessitated imports of liquefied natural gas, increased defence spending, Ukrainians fleeing their country, shortage of raw materials, negative impact on emerging and developing countries, and the death of thousands of soldiers and civilians. [read post]
16 Aug 2023, 7:15 pm by Kurt R. Karst
  FDA took issue with the representation that there was a 49% observed relative difference in all cause mortality with Breztri v. [read post]
16 Aug 2023, 11:08 am by Bill Marler
Even after the Court’s twisted opinion in Supreme Beef v. [read post]
16 Aug 2023, 8:07 am by Lynn L. Bergeson and Carla N. Hutton
In the case of nanomaterials not listed in Annexes IV, V, and VI, notifications must include additional data on the safety of the nanomaterial for use in cosmetic products. [read post]
9 Aug 2023, 4:18 am by Eric Segall
As Sloan documents, the relationships between and among some of the justices were raw and seemingly much more tense than today. [read post]
1 Aug 2023, 7:22 pm by Patti Waller
V. vulnificus infection is an extremely rare illness. [read post]
1 Aug 2023, 3:36 pm by News Desk
   “The identification of these severe cases, including one fatality, due to V. vulnificus is concerning,” said DPH Commissioner Manisha Juthani, MD. [read post]