月：2010年2月

華盛頓法律基金會發表了一封由海曼，菲爾普斯和麥克納馬拉，P.C。，律師Jeffrey N. Wasserstein和Nisha P. Shah撰寫的法律意見信。這篇文章以“法院授權Qui Tam被告起訴第三方賠償”的文章，對我們的…擴展……

By Kurt R. Karst – FDA’s Office of Generic Drugs (“OGD”) has a backlog of Abbreviated New Drug Applications (“ANDAs”) that is nearing 2,000, according to OGD Director Gary Buehler, who presented the data at the recent Generic Pharmaceutical Association (“GPhA”) Annual Meeting. OGD’s median …

By Kurt R. Karst – In yet another setback to the Federal Trade Commission’s (“FTC’s”) battle against settlement agreements between brand name and generic drug companies – so-called “reverse payments” or what the government now calls “pay-for-delay” agreements – the U.S. District Court for the …

作者：艾倫·基爾森鮑姆（Alan Kirschenbaum） - 為了挽救醫療保健改革，奧巴馬政府將於2月25日星期四舉行兩黨醫療保健改革會議。受到邀請是雙方的國會領導，主席，主席和涉及健康委員會的成員……

戴維·B·克裏斯德（David B.FDA相信…

威廉·庫斯塔斯（William T. Koustas）撰寫 - FDA宣布將需要所有稱為促紅細胞生成劑的藥物（“ ESA”）才能具有風險評估和緩解策略（“ REMS”）。目前，這類藥物僅限於三種Amgen產品：Procrit，Epogen（兩者都…

作者：Ricardo Carvajal和A. Wes Siegner - 根據FTC發布的新聞稿，該機構“已向11家公司發送了信件他們是這樣 …

Douglas B. Farquhar撰寫的 - 新澤西聯邦法院的最新消息必將鼓勵一些由FDA批準的長時間銷售藥物的製造商提起競爭者，這些競爭對手繼續推銷同一藥物的未批準版本。Mutual Pharmaceutical Company，Inc。和…

Ricardo Carvajal - 為了授予FDA對飲食補充劑的額外權限，參議員約翰·麥凱恩（John McCain）和拜倫·多根（Byron Dorgan）介紹了2010年的《飲食補充安全法》。該法案將要求飲食補充劑設施為FDA提供有關補充劑和…的信息……

By Alan M. Kirschenbaum – Late last year, we reported on a decision of the D.C. District Court upholding the Department of Defense’s ("DOD’s") authority to apply Federal Ceiling Price ("FCP") limitations to all prescriptions filled on or after January 28, 2008 under the TRICARE …

庫爾特·凱斯特（Kurt R.依靠…

Hyman, Phelps & McNamara's Jeffrey N. Wasserstein (co-chief blogger at fdalawblog.net and self-described social media guru) will be speaking on the regulation of social media at the American Conference Institute’s 8th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry, taking place in …

作者：Kurt R. Karst - FDA強迫處方開關開關（“ RX-to-OTC開關”）的能力在過去十年中一直受到激烈的競爭。關於強迫RX到OTC開關的辯論的關鍵是FDA是否沒有新的藥物申請（“ NDA”）讚助商的同意，具有權力……

作者：米歇爾·巴特勒（Michelle L. Butler） - 本周，溫斯頓實驗室案的當事方對美聯儲提出了偏見的解雇規定。R. Civ。P. 41（a）。該案件涉及FDA對“會員”一詞的解釋，以決定拒絕溫斯頓一小……

By Kurt R. Karst – Late last month, FDA denied a citizen petition submitted by Graceway Pharmaceuticals, LLC (“Graceway”) requesting that the Agency refuse to approve Abbreviated New Drug Applications (“ANDAs”) for generic versions of Graceway’s ALDARA (imiquimod) Cream, 5%, unless such applications contain, among …