Despite the dosing concerns, however, the advisory panel voted 23-0 in favor of recommending Xtampza for approval. The FDA generally follows the advice of advisory panels, although it is not obligated to do so. While the FDA stated days prior to the panel meeting that Collegium’s packaging should contain a clearer warning about the dosing issue, it did not explicitly state that approval was contingent on labeling improvements.
The blast at the West Fertilizer plant killed 15 people altogether, injured 170, damaged nearby buildings and over 150 homes in the city of West, obliterating the plant, and even caused the equivalent of a 2.1 magnitude earthquake. With jury selection set to begin on Monday, authorities for the county told hundreds of prospective jurors on Sunday evening that they would not be needed for the trial involving the plant’s ownership and suppliers and the families of the deceased; Kevin Sanders, William Uptmor and Kenneth Harris. Waco District Court Judge Jim Meyer had divided the litigation regarding the explosion into three separate lawsuits, with the aforementioned case serving as a potential bellwether for the other two cases, which will contain hundreds of plaintiffs.
The 2-1 panel decision in favor of the attorneys general of 18 states follows a similar ruling issued in late August in North Dakota federal court in a separate lawsuit involving 13 states. That stay was ordered a day before the rule was to have gone into effect. The most recent ruling, which was a consolidated appeal of four separate lawsuits by the states and other interest groups, greatly expands the geographically-limited North Dakota decision and instead blocks the majority of the country from the Obama-led initiative.
Despite the grim news, the conviction may actually increase the odds for a diplomatic solution. Late last month, Iranian President Hassan Rouhani strongly indicated the desire for a prisoner swap. Currently, 19 Iranians are being held within the U.S. for violating its sanctions policy against Iran. In an interview with CNN’s Christine Amanpour, Rouhani said “If the Americans take the appropriate steps and set them [Iranians held in the U.S.] free, certainly the right environment will be open and the right circumstances will be created for us to do everything within our power and our purview to bring about the swiftest freedom for the Americans held in Iran as well.” Secretary of State John Kerry told reporters Sunday night “I have yet to hear directly from the Iranians on anything direct,” adding that, “We’ve had some conversations but … we’ll wait and see where we are.”
Congressman Fitzpatrick’s law simply reads: “Not later than 60 days after the date of enactment 8 of this Act, the Commissioner of Food and Drugs shall issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure System.” Essure Problems is also asking others who have experienced complications from the device to also send their Representatives this letter (which is provided in Word Doc. Format at the bottom of the page).
It appears that there is no viable candidate that could possibly satisfy the 42-member far-right Freedom Caucus or the Tea Party, and still garner the 218 votes needed for election without requiring the help of Democrat votes. The Freedom Caucus, who backed conservative Floridian Daniel Webster, essentially pushed McCarthy to drop out of consideration. There is one ‘non-candidate,’ however, who looks poised to deliver the GOP from its internal division, having the consensus support of nearly the entire Republican Party: former vice-presidential nominee and House Ways and Means Committee Chairman Paul Ryan (R-WI).
In addition to the offending parties, the investigation, which is still ongoing, raises questions into the conduct of the Emanuel administration. Speaking of the charges Thursday following and awards banquet, the mayor said that he was “both disappointed (and) saddened by the details around the charges.” Emanuel added, “I think when people serve the public, they should uphold the trust the public puts in them. At least based on the details around the charges, that wasn’t the case here.” Nobody from the administration was subpoenaed during the investigation according to spokesperson Kelly Quinn; but given the connection between Solomon, who also helped recommend Jean-Claude Brizard, who Byrd-Bennett succeeded, as Emanuel’s first CPS CEO in 2011, speculation of foreknowledge remains high.
Williams’ announcement came minutes after Thursday’s midnight strike deadline, and it also comes exactly a week after UAW representatives announced that the 36,000 hourly and 4,000 salaried UAW members rejected the previous contract agreed on by the union and Fiat-Chrysler management by a sizable 65 to 35 margin. Williams said that there were changes made to this agreement from the one rejected, although he has yet to specify the differences. The deal will stave off the immediate threat of a strike, but it still must be approved both UAW local leaders and its members.
There are no federal regulations on the use of pesticides on marijuana plants because it is still considered to be an illegal crop at the federal level; however Colorado authorities did release a list of approved treatments, with Eagle 20 not being on the approved list. Flores justified filing the suit by saying, “I want these companies to take a step back and look at what they are putting into their products. These warehouses are getting big and really sloppy. They are adding chemicals to make things more efficient and more potent.
The proposed regulation would not completely ban the practice in its entirety, but instead force to add a section that states that the arbitration procedures do not apply if a complaint has been certified by a judge for class-action litigation. Codrary said about the provision, “Under this proposed approach, consumers would again get their day in court to hold companies accountable for potential wrongdoing. We think that’s quite important.” The rule would also require companies to publicly post which claims have been brought to arbitration and the awards issued.