http://www.mmm-online.com/opdp/topic/13957/ Articles tagged with OPDP from Medical Marketing and Media MMM mmmsubs@haymarketmedia.com no Aveo CRL says company's kidney drug information is uninterpretable; Dynavax has to find more hepatitis B clinical trial patients; Gilead's hep C drug gets priority status; OPDP slaps Janssen and Sigma Tau with untitled letters. http://www.mmm-online.com/business-briefs-aveo-dynavax-gilead-opdp/article/297144/ Mon, 10 Jun 2013 18:01:16 GMT Aveo CRL says company's kidney drug information is uninterpretable; Dynavax has to find more hepatitis B clinical trial patients; Gilead's hep C drug gets priority status; OPDP slaps Janssen and Sigma Tau with untitled letters. MMM Plan B age limits retained and rejected, Celgene drugs gets expanded indication, Komen cuts back on walks, Apple is policing medical apps, OPDP director's Q&A http://www.mmm-online.com/business-briefs-teva-celgene-komen-apple-opdp/article/296684/ Thu, 06 Jun 2013 17:47:33 GMT Plan B age limits retained and rejected, Celgene drugs gets expanded indication, Komen cuts back on walks, Apple is policing medical apps, OPDP director's Q&A MMM The FDA wants to know how physician attitudes towards direct-to-consumer advertising have evolved since the agency last asked them, in 2002. If a snap poll by CMI/Compas is any indication, drug companies probably won't like the answers. http://www.mmm-online.com/docs-havent-mellowed-on-dtc-snap-poll-suggests/article/291567/ Wed, 01 May 2013 18:18:45 GMT The FDA wants to know how physician attitudes towards direct-to-consumer advertising have evolved since the agency last asked them, in 2002. If a snap poll by CMI/Compas is any indication, drug companies probably won't like the answers. MMM FDA's Office of Prescription Drug Promotion is taking an integrated approach to reviewing promotional materials and shedding its consumer- and professional-directed silos. http://www.mmm-online.com/opdp-takes-an-integrated-approach-to-ad-reviews/article/283556/ Fri, 08 Mar 2013 16:13:32 GMT FDA's Office of Prescription Drug Promotion is taking an integrated approach to reviewing promotional materials and shedding its consumer- and professional-directed silos. MMM What the agency writes in a recent warning letter to a dietary supplement firm is instructive with regard to "Liking" off-label posts. http://www.mmm-online.com/amarc-angst-has-fda-put-pharma-facebook-likes-in-the-crosshairs/article/283541/ Fri, 08 Mar 2013 14:47:43 GMT What the agency writes in a recent warning letter to a dietary supplement firm is instructive with regard to "Liking" off-label posts. MMM With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss. http://www.mmm-online.com/sequester-cuts-could-snarl-approvals-for-years/article/283295/ Wed, 06 Mar 2013 19:20:47 GMT With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss. MMM PhRMA issued a terse response to a study claiming that ED drug advertisers more or less ignored the trade group's Guiding Principles for Direct to Consumer ads, a self-policing regime implemented in 2005 to fend off talk of a ban on drug ads. http://www.mmm-online.com/razzed-for-lax-dtc-self-policing-phrma-accentuates-the-positive/article/282684/ Fri, 01 Mar 2013 19:13:39 GMT PhRMA issued a terse response to a study claiming that ED drug advertisers more or less ignored the trade group's Guiding Principles for Direct to Consumer ads, a self-policing regime implemented in 2005 to fend off talk of a ban on drug ads. MMM A Merck study bolsters FDA's case for requiring that TV ads for prescription drugs present risks in text as well as the voiceover. http://www.mmm-online.com/merck-finds-dual-modality-in-dtc-helps-viewers-grasp-risks/article/274726/ Thu, 03 Jan 2013 20:54:48 GMT A Merck study bolsters FDA's case for requiring that TV ads for prescription drugs present risks in text as well as the voiceover. MMM AstraZeneca's 7,300 layoffs were not the last word for 2012, Alcon gets hit with an untitled letter from OPDP, and Novo creates an all-diabetic sports team http://www.mmm-online.com/company-news-astrazeneca-alcon-novo-nordisk/article/271323/ Wed, 05 Dec 2012 20:30:30 GMT AstraZeneca's 7,300 layoffs were not the last word for 2012, Alcon gets hit with an untitled letter from OPDP, and Novo creates an all-diabetic sports team MMM The FDA has issued a rare untitled letter concerning a pitch letter - a reminder that the agency does not consider press materials to be exempted from its oversight. http://www.mmm-online.com/with-untitled-letter-fda-signals-press-materials-arent-exempt/article/269255/ Tue, 20 Nov 2012 19:37:35 GMT The FDA has issued a rare untitled letter concerning a pitch letter - a reminder that the agency does not consider press materials to be exempted from its oversight. MMM