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…on the basis of preemption. Second, in McNellis ex rel. DeAngelis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006), the U.S. District Court for the District of New…
…marketed unapproved drugs “present direct challenges to [the drug approval system], as do unapproved drugs that directly compete with an approved drug, such as when a company obtains approval of…
Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of old meds flowing out the door We will, we will,…
By Kurt R. Karst – Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA,…
…that will be provided to manufacturers from summary-level information to claims-level information, including, among other things, date of dispensing, prescription number, and pharmacy identifier. Exhibit A to the Agreement provides…
…2003, FDA published final regulations (21 CFR §§ 314.50(l), 314.94(d), 601.14(b), and 314.81(b), respectively) requiring drug manufacturers to ectronically submit to FDA specific labeling content for new drug applications, abbreviated…
…(i.e., NDA or BLA) prescription drugs (excluding orphan drugs) made to or reimbursed by Medicare, Medicaid, the Department of Veterans Affairs (“VA”), the Department of Defense (“DoD”), and the TRICARE…
…prescription-related letters to customers, but if they profit from sending the letters, they must disclose that information to recipients. In Kelley v. CVS Pharmacy, the plaintiff, Jeffrey Kelley, used a…
…by a facsimile to (540) 231-9293, or by snail mail, using the address below. Virginia Tech Center for Applied Health Sciences Attention: Angela Correa 123 Duckpond Drive, mailcode 0418 Blacksburg,…
…duration of the interruption; Whether an API is a reason for, or risk factor in, the discontinuation or interruption, and, if so, the API source and any alternatives; and, Whether…
In two previous posts (here and here), we reported on a trend in Warning Letters issued by FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) that focuses on ensuring…
…the claims for strict liability, breach of warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale would (if successful) impose state “requirements” that differed from, or added to,…
…We know that, in the context of payor communications, the Office of Prescription Drug Promotion (and before it, the Division of Drug Marketing, Advertising and Communications – DDMAC) has long…
…companies to leverage its processes and submit complaints. We speculated that, “[g]iven the drop in OPDP enforcement letters, NAD may represent a new venue for industry looking to challenge competitor…
…component “complete TV broadcast.” Component 1 was one of the disease awareness videos cited by FDA, Component 2 was “brought to you by Emgality,” and lastly, Component 3 was a…