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…force PBMs to pass manufacturer rebates through to pharmacies to lower the out‑of‑pocket costs of government beneficiaries at the pharmacy counter. The exclusion from the discount safe harbor had a…
…first decision dealing with the 180-day notice of commercial marketing provision at PHS Act § 351(l)(8)(A) created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) since the…
…earlier and in another agency – the Federal Trade Commission. In September 2008, the FTC announced enforcement actions against 11 sellers of bogus cancer cures. One of these 11 companies…
…Order granting the government’s motion for an Order to Show Cause. We will post a more detailed analysis of the Bayer case and its potential effects in the coming days. …
…whether they complied with human subject protection guidelines; a “full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation” of the product; and …
…DIMETAPP Extentabs containing 12 mg of brompheniramine maleate and 75 mg of phenylpropanolamine HCL. “In its final order, [FDA] concluded that all extended-release drug products subject to the notice (e.g.,…
…a listed drug on the “date of approval” of the NDA or ANDA (see section V.A.3). Revises the definition of “substantially complete application”- to describe an ANDA that on its…
…new layer of craziness for companies, adding a price-gouging regulatory framework that is a patchwork of little-used state laws, brand new federal and state executive orders, and a federal law…
…us quickly noticing. That recently happened when Prometheus Laboratories Inc. (“Prometheus”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction in the U.S. District Court for…
By Kurt R. Karst – In what is, to our knowledge, the first instance in which a company has asserted the patent delisting counterclaim provisions added by the Medicare Modernization…
…may be distributed by a company without violating the misbranding provisions of the FDC Act. See, e.g., United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Op. and Order,…
…to R product. The proposed generic product need not have the same formulation design as the R product. In order to adequately compare R and T products, a potential ANDA…
…their patients.” (FN 5). FDA notes that hospital compounding and distribution varies: Some compound only for use and administration within the hospital and others compound for distribution throughout a broader…
…suspicious order reporting and monitoring. DEA stated that, short of providing arbitrary thresholds to distributors, “it cannot provide more specific suspicious orders guidance because the variables that indicate a suspicious…
…for an individually identified patient. Section 503A has always permitted compounders to compound copies of shortage medications (which are not, by definition, “essential copies” of commercially available drug products). Never…