庫爾特·凱斯特（Kurt R. Karst） - 萬聖節快樂！本周早些時候，Health News Daily報道說，公共公民健康研究小組主任Sidney Wolfe博士被任命為FDA藥物安全和風險管理谘詢委員會的常任成員。沃爾夫博士課程的副本…
菜單
月：2008年10月
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Public Citizen’s Sidney Wolfe Joins FDA Advisory Committee 2008年10月31日
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第301條（LL）更新：FDA NDI響應不是FDC Act§301（LL）的安全港；FDA提供特定於派對的評論 October 30th, 2008
By Ricardo Carvajal – In its most recent response letters to New Dietary Ingredient ("NDI") notifications submitted pursuant to FDC Act § 413(a)(2), FDA included the following paragraph: Based on the information in your submission, it is possible that a recently enacted law may affect the legal status of …
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Warning Letters Confirm That FDA Views Combination OTC Drug/Dietary Supplement Products As Unapproved New Drugs October 29th, 2008
By Ricardo Carvajal & Kurt R. Karst – On October 28, 2008, FDA announced that the Agency issued Warning Letters to Bayer HealthCare contending that two of Bayer’s products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage (Heart Advantage), are unapproved …
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FDA Rules that Hi-Tech Forfeited 180-Day Exclusivity Under Reasoning Similar to the Agency’s Acarbose Decision; Changes Called for in FDA Exclusivity Decision-Making October 28th, 2008
By Kurt R. Karst – Further cementing FDA’s position that a generic applicant can forfeit 180-day exclusivity after patent information is "withdrawn" by the NDA holder, FDA ruled earlier today that Hi Tech Pharmacal Co., Inc. (“Hi Tech”) forfeited 180-day exclusivity after the information on two exclusivity-qualifying Orange …
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CPSC Posts Sample General Certification of Conformity Form and FAQ October 27th, 2008
By Anne Marie Murphy — We recently posted on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), which makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Section 102(a)(1) of CPSIA amends the Consumer Product Safety Act (“CPSA”) …
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Off-label Promotion Qui Tam Suits – a YouTube Video by HP&M’s John R. Fleder October 24th, 2008
Hyman，Phelps＆McNamara，P.C。的John R. Fleder現在出現在華盛頓法律基金會“合法簡短” YouTube視頻中。弗萊德先生在6分鍾的視頻中指出，私人舉報者最新的聯邦虛假索賠法案案件的增加，基於所謂的“非標簽”使用涉及製藥公司的促銷活動，並解釋了為什麼最近的法院裁決被駁回…
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歐洲藥品行業呼籲歐盟遏製藥品的平行交易 2008年10月22日
Earlier this month, European drug makers called on the European Union (“EU”) to act on the issue of parallel trading of pharmaceuticals by confining prices for drugs to the specific EU member country they are initially sold. Drug makers argue that some form of price …
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引入FDC Act§505（Q）公民請願跟蹤器。。。。 October 21st, 2008
Last week, I presented at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes with Geoff Levitt of Wyeth on citizen petitions. The focus of my talk was on new FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain …
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Just in Time for Halloween, FDA Issues its Highly Anticipated “Treat and Trade” Draft Guidance on the New Tropical Disease Priority Review Voucher Program 2008年10月20日
2008年10月20日，FDA宣布有一份備受期待的指南草案，標題為“熱帶疾病優先審查憑證”。指南草案討論了FDA對FDC Act§524的實施 - “優先審查以鼓勵熱帶疾病治療”，這是補充的……
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Hyman，Phelps＆McNamara，P.C。宣布兩名新董事和律師 October 19th, 2008
Hyman，Phelps＆McNamara，P.C。很高興宣布，安妮·瑪麗·墨菲（Anne Marie Murphy）和米歇爾·巴特勒（Michelle L.墨菲女士的實踐專注於藥物開發問題。她服務…
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FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling October 17th, 2008
FDA的組合產品辦公室（“ OCP”）最近發布了一份標題為“設備以及批準的藥物和生物產品的新對比度成像指示注意事項”草案。該指南草案允許診斷成像設備製造商擴展標簽，以與對比劑或放射性藥物使用…
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FDA Issues Draft Guidance on Potency Tests for Cellular and Gene Therapy Products October 16th, 2008
FDA最近發布了有關細胞和基因療法效力測試（“ CGT”）產品的新指南草案。《 FDC法》要求所有生物產品在批準此類產品之前符合安全，純度和效力的代理要求，但從曆史上看，該機構和…
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Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the Internet October 15th, 2008
為了消除流氓藥房從互聯網上分配受控物質，國會通過了修改《管製物質法》（“ CSA”）的立法。《瑞安·海特法案》（H.R. 6353），尊敬的是一名死於過量的受控藥物，該少年在互聯網上獲得的藥物，…
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Citizen Petition Filed Under FDC Act § 301(ll) Takes Aim at Stevia Sweeteners 2008年10月14日
已向FDA提交了一份公民請願書，要求該機構根據第301（ll）采取監管行動，以添加植物性甜葉菊redaudiana中存在甜味化合物的任何食物，以這些化合物（被稱為Stepeviol Glycosides）為由是 …
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FDA增加了骨質疏鬆症的“鈣和維生素D”健康索賠 2008年10月14日
FDA最近發布了一項最終規則，用於擴展和簡化與骨質疏鬆症風險降低有關的健康索賠。自2010年1月1日起，公司可能會使用新簡化的鈣和維生素D產品的健康索賠，以及與骨質疏鬆症風險降低有關的鈣產品。…