OPDPRESOURCES.COM
OPDP ResourcesOPDP Resources is a curated collection of resources relating to FDA's regulation of prescription drug promotion
http://www.opdpresources.com/
OPDP Resources is a curated collection of resources relating to FDA's regulation of prescription drug promotion
http://www.opdpresources.com/
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OPDP Resources | opdpresources.com Reviews
https://opdpresources.com
OPDP Resources is a curated collection of resources relating to FDA's regulation of prescription drug promotion
opdpresources.com
Education — OPDP Resources
http://opdpresources.com/educational-resources
Books, conferences and other educational opportunities. FDA Requirements for Prescription Drug Promotion. By John Driscoll, RAPS (2013). Read. For free on the RAPS website. FDA Advertising and Promotion Manual. Thompson Publishing Group (updated monthly). Using Social Media in FDA-Regulated Industries: The Essential Guide. Effective Review and Approval of Digital Promotional Tactics. By Dale Cooke, FDLI (2013). Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA.
FDA Links — OPDP Resources
http://opdpresources.com/fda-links
An organized collection of links to regulatory information provided by FDA on its website. Submission of Social Media. Accelerated Approval Subm issions. Television ads for advisory comment. DTC TV Ad Pre-Dissemination Review Program. Launch materials for advisory comment. FDA-Track: Number of Core Launch Reviews. Completed within 45 Days. Other materials for advisory comment. For additional resources relating to OPDP enforcement letters. FDA-Track: Number of Complaints. Of the January 30 webinar. Specif...
Recommended Reads — OPDP Resources
http://opdpresources.com/recommended-reads
Recommended articles, presentations and other materials. Compliance Challenges within Medical Affairs. By Thomas Sullivan,. June 2014) to "scientific exchange" Citizen's petition. 7/2011) and follow-on petition. 9/2013) submitted by Ropes and Gray and Sidley Austin LLP on behalf of seven product manufacturers. How to Determine a Pharmaceutical Product's 'Country of Origin'. Public Contract Law Journal. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. Increased FDA S...
Enforcement Letter Resources — OPDP Resources
http://opdpresources.com/enforcement-letters
Online resources and articles specifically relating to enforcement letters issued by OPDP. All OPDP/DDMAC enforcement letters (since 1997). On the FDA website. Of FDA website for OPDP/DDMAC letters with the word "misleading" replace "misleading" in the search box to search other terms. CY 2013 OPDP Enforcement Summaries. Covington and Burlington E-Alerts. Monthly and end-of-year summaries of FDA promotional letters, including OPDP). 2012 End-of-Year Summary of FDA Promotional Enforcement Activity. BMC He...
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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