月：2011年5月

Ricardo Carvajal撰寫 - FDA發布了一份執法酌處權，用於使用某些合格的健康索賠，以在雀巢營養（Gerber）銷售的嬰兒公式（Gerber）上標記。FDA的信中提供的主張是：很少有科學證據表明，對於健康的嬰兒……

傑米·沃爾斯（Jamie K.作為試劑和儀器。上周FDA發布了…

By Kurt R. Karst – Last Friday, Nostrum Pharmaceuticals, LLC (“Nostrum”) lodged a Complaint against FDA in the U.S. District Court for the District of New Jersey seeking declaratory and injunctive relief arising from the Agency’s decisions on pre-Medicare Modernization Act (“MMA”) 180-day exclusivity with respect …

庫爾特·凱斯特（Kurt R.提交…

By Ricardo Carvajal – Seaside Farm, Inc., a South Carolina tomato farmer, has sued the federal government under the Federal Tort Claims Act to recoup losses allegedly suffered as the result of the government’s misidentification of fresh tomatoes as the culprit in the outbreak of Salmonella Saintpaul …

作者：Riëttevan Laack和Ricardo Carvajal - 正如我們幾次報道的那樣（參見，例如，此處和此處），最近的聯邦貿易委員會（“ FTC”）關於與健康相關的索賠的同意令，包括要求的要求，包括1）批準某些索賠。根據《營養標簽和教育法》的FDA。

By Kurt R. Karst – The Federal Trade Commission’s (“FTC”) drumbeat of opposition to patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) grew louder last week with the Commission’s submission of an amicus brief with the U.S. Court of Appeals for the …

Susan J. Matthees - FDA將截止日期延長到2011年6月6日至7月5日的菜單標簽上的擬議規則（請參閱我們的上一篇文章）。FDA在5月24日在聯邦公報上發布的通知中說，

艾倫·基爾森鮑姆（Alan M.。該計劃，根據節的授權…

Ricardo Carvajal撰寫 - 在一份名為“海鮮安全：FDA需要改善進口海鮮並更好地利用有限資源的報告中，” Gao發現了FDA進口海鮮安全計劃的許多方麵的缺點。GAO通過注意更多…來為其審查奠定了基礎。

約翰·吉爾伯特（John A. Gilbert）和卡拉·帕爾默（Karla L.2000年的“ Cafra”）。當最終確定時，規則將…

Hyman，Phelps＆McNamara，P.C。最近的文章出現在FDLI Update中。助理Peter M. Jaensch探討了各州的立法努力，要求對含有甲基苯丙胺前體的產品（例如偽麻黃堿和麻黃堿）進行處方，並將其列為受控物質。先生。 …

By Kurt R. Karst – Last Friday, ISTA Pharmaceuticals, Inc. (“ISTA”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District Court for the District of Columbia seeking to vacate FDA’s May 11, 2011 approval of Coastal …

By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V. notifying them that the Bureau believes the companies violated …

Recently, we were perusing FDA-TRACK (Transparency, Results, Accountability, Credibility, Knowledge-sharing), FDA’s “web-based tool for tracking progress on key activities throughout the agency and making the information available both internally and to external stakeholders and the public,” and the FDA-TRACK Health Care Reform Dashboard in particular, …