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…following provisions are not included in previously introduced H.R. 4299: Clarify terminology in the CSA for the terms: “consistent with the public health and safety” and “imminent danger,” which, Senator…
…was HRSA’s long-overdue rulemaking aimed at implementing those ACA provisions. Despite unsuccessful attempts by Congress to repeal and replace the ACA since that Executive Order was issued, the Executive Order…
By Kurt R. Karst – When Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia noted in a January 12, 2015 Minute Order that the…
…state in which the registrant is licensed: Charles Syzman, D.O., 81 Fed. Reg. 64937 (Sept. 21, 2016) Richard J. Settles, D.O., 81 Fed. Reg. 64940 (Sept. 21, 2016) Kevin L….
…the company’s memorandum, the company says it’s not really necessary, because the inquiry should end at Step One, as the statute is clear: FDA’s position is fatally inconsistent with the…
…to note that compliance with the lower court’s order to produce the deliberative documents would be overly burdensome. After a negotiated narrow search of just three document custodians, FDA identified…
…potentially proposing further notice-and-comment rulemaking” and whether further action is appropriate. Several compounding guidance documents (see chart below) were published within Priebus “window” because they are still within their comment…
…final rule implements the following changes: Allows unlimited reexports among EEA countries; Eliminates the 180 day period to complete reexport from the first country to the second country and subsequent…
…order), and cannot be offset by manufacturer discounts on other NDCs or discounts on the same NDC made on other transactions, orders, or purchases. Instances of overcharging can be associated…
…submit to Medicaid for pharmaceuticals. The OIG long ago removed a requirement that charge-based providers disclose the amount of discounts on claims submitted to Federal programs. 64 Fed. Reg. 63518,…
…3-year exclusivity: in order for 3-year exclusivity to have an effect against a competitor’s product, both drug products must share the same conditions of approval and share an active moiety….
…their component parts into interstate commerce. Complaint at 6. Specifically, the government alleged that the cheese products had been prepared, packed or held under insanitary conditions whereby they may have…
…resolved in a joint Stipulation and Order (“Settlement Agreement”) that was filed yesterday, December 14. The Settlement Agreement contains a number of important provisions. These include: The Warning Letter issued…
…rule. Fish of the order Siluriformes from families other than Ictaluridae, which are subject to this rule, must be labeled with an appropriate common or usual name other than catfish…
…for [COMPANY’S BRAND-NAME DRUG]. However, due to [COMPANY’S] marketing exclusivity rights, this drug product is not labeled with that pediatric information.”) Specifically, FDC Act § 505A(o) states: (1) GENERAL RULE.—…