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PhillyCooke Consulting21st century FDA ad-promo compliance
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21st century FDA ad-promo compliance
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21st century FDA ad-promo compliance
regulatoryrx.blogspot.com
PhillyCooke Consulting: Prescription Products Don't Exist, But I Talk About Them Anyway
https://regulatoryrx.blogspot.com/2014/08/prescription-products-dont-exist-but-i.html
21st century FDA ad-promo compliance. Prescription Products Don't Exist, But I Talk About Them Anyway. I use the phrase "prescription products" quite frequently. Technically, I'm misusing the phrase, but I prefer to think of it as a shorthand term of art. By "prescription products," I mean all of those products whose promotional labeling and advertising is subject to FDA regulation. That includes prescription drugs, biologics, vaccines, and restricted medical devices. Tuesday, August 26, 2014.
PhillyCooke Consulting: December 2015
https://regulatoryrx.blogspot.com/2015_12_01_archive.html
21st century FDA ad-promo compliance. Google SEM Changes Update. In June, Google announced changes to the ways search engine marketing (SEM) would work for marketers of prescription drugs. The background on the changes and the full original update is available here. Recently, Google has provided additional detail about the new vanity URL policy, some new options, and hard dates for implementation. First a quick backgrounder (see the earlier post. For a more extensive background). For SEM ads, marketers o...
PhillyCooke Consulting: Redirecting Ads
https://regulatoryrx.blogspot.com/2014/09/redirecting-ads.html
21st century FDA ad-promo compliance. Updated slightly to correct grammar and spelling, and to improve clarity. About search engine marketing for pharmaceutical products, I talk about a category of communications called Redirecting Ads. These ads have the following characteristics:. The ads link to a product site. Do not mention a specific product. Do not imply a specific product. The meaning of the silence is debatable. Did FDA think that such ads were outside its purview (this is my view, BTW)? In the ...
PhillyCooke Consulting: Consulting & Training
https://regulatoryrx.blogspot.com/p/phillycooke-consulting.html
21st century FDA ad-promo compliance. PhillyCooke Consulting focuses on five key areas: Promotional Review, Training, Process Improvement, Policy, and MLR Submission Preparation. Introduction to Pharmaceutical Marketing. How to Effectively Integrate Digital Tactics into Promotion. Developing Compliant Paid Search Campaigns. Social Media Guidance: State of the Industry. PhillyCooke Consulting also offers Master Classes providing in-depth training on the latest topics. For more on current offerings, co...
PhillyCooke Consulting: "Reminder-like" Promotions
https://regulatoryrx.blogspot.com/2014/10/reminder-like-promotions.html
21st century FDA ad-promo compliance. This week at the Food and Drug Law Institute's Advertising and Promotion Conference. FDA made a subtle, but vital, clarification in the context of discussing the scope of its guidance on space-limited contexts. The clarification came on the penultimate slide. The key distinction for reminder-like promotion vs. reminder promotion is that reminder-like promotion must have an"[a]ccompanying PI or brief summary" and a statement to "Please see." the accompanying P...Quant...
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Pharma Blogs — OPDP Resources
http://opdpresources.com/blogs
A list of influential blogs, other online journalism and resources relating to FDA and prescription drug promotion. RAPS News and Features). Alec Gaffney's Regulatory Feeds/Websites. Top 25 Regulatory Twitter Accounts. Federal Register Notice Tracking Tool. Hyman, Phelps and McNamara). Advertising and Promotion (DDMAC/OPDP). PhillyCooke's Regulatory Rx Blog. Considerations for deciding on an electronic review system. Ed Silverman @ Forbes. Eye on FDA's public list.
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Regulatory Risk Management
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Regulatory Surveillance and Management System
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PhillyCooke Consulting
21st century FDA ad-promo compliance. At the beginning of November, FDA announced. Its intention to conduct a study looking at the so-called "one-click rule." As readers of this blog know, I've termed this, " The 'Rule' That Isn't. The basic idea behind any version of the one-click rule is that companies can meet their fair balance requirement ( 21 CFR 202.1(e)(5)(ii). By including a hyperlink to the risk information, rather than by providing the risk information itself in the original communication.
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Regulatory & Safety Industry News - Markets & Regulations - Drinks Business Review
Jump to page content. For enhanced features Forgotten Password? Energy and Sports Drinks. New Style of IT. Regulatory and Safety Home. Return to: DBR Home. Select a Drinks sector. Energy and Sports Drinks. Mother Dairy milk samples found tainted in India. By DBR Staff Writer. Mother Dairy's full cream and toned milk samples were found to contain detergent and frozen fat, according to Ghaziabad Food and Drugs Administration (FDA). By DBR Staff Writer. China probes distillers over tainted alcohol. The gove...
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Regulatory Science at Georgetown University | Georgetown University
Skip to main content. Georgetown University Medical Center. Regulatory Science at Georgetown University. Meet Our Faculty and Staff. Events, News, and Funding Opportunities. Georgetown University Medical Center. School of Nursing and Health Studies. Georgetown Lombardi Comprehensive Cancer Center. Biomedical Graduate Research Organization. MedStar Georgetown University Hospital. Admissions and Financial Aid. Regulatory Science at Georgetown University. PRSM aims to engage a wide community of scientists, ...
Regulatory Science Associates: toxicologists, ecotoxicologists
General/Specialty Chemicals: More Details. General/Specialty Chemicals: Recent Projects. Our Areas of Expertise. Sandra Allen BSc PhD CBiol MSB. Paula Batten BSc PGD. Alison Brammer BSc, DLSHTM, MSc. Charlotte Croudace BSc MSc. Barry Elliott BSc MSc PhD. Prof John Foster PhD, DipRCPath, FRCPath, Hon FBTS, FIATP. Mike Hall BSc Hons GRSC. Judy Knight BSc Hons. Gill Milburn BSc Hons. Mary Moxon BSc MSc. Jenny Odum BSc MSc PhD. Mac Provan BSc PhD. Helen Prior BSc (Hons), MSc, PhD, FSB, DSP.
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