http://www.mmm-online.com/james-g-dickinson/author/79/ Latest articles by James G. Dickinson from Medical Marketing and Media MMM mmmsubs@haymarketmedia.com no Appendages of the HHS secretary's apron strings, FDA commissioners must toe the "party line" http://www.mmm-online.com/as-i-see-it-activism-and-the-fda/article/290095/ Wed, 01 May 2013 04:00:00 GMT Appendages of the HHS secretary's apron strings, FDA commissioners must toe the "party line" MMM FDA drug safety officials say that an influx of numerous bleeding reports associated with Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) is a case of "stimulated reporting" http://www.mmm-online.com/fda-pradaxa-fell-prey-to-stimulated-reporting/article/290097/ Wed, 01 May 2013 04:00:00 GMT FDA drug safety officials say that an influx of numerous bleeding reports associated with Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) is a case of "stimulated reporting" MMM Organization including the Pew Charitable Trusts are voicing basic suppor for FDA's efforts to develop an alternative approval pathway for certain drugs http://www.mmm-online.com/new-approval-paths-needed-report/article/290100/ Wed, 01 May 2013 04:00:00 GMT Organization including the Pew Charitable Trusts are voicing basic suppor for FDA's efforts to develop an alternative approval pathway for certain drugs MMM The idea of scaling back premarket clinical trials comes under fire http://www.mmm-online.com/conditional-approval-draws-dissent/article/285618/ Mon, 01 Apr 2013 04:00:00 GMT The idea of scaling back premarket clinical trials comes under fire MMM FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality http://www.mmm-online.com/drug-quality-is-fdas-top-2013-priority-hamburg/article/285617/ Mon, 01 Apr 2013 04:00:00 GMT FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality MMM FDA is exploring an alternative drug-approval pathway for drugs intended to address unmet medical needs by "limited use" approvals. http://www.mmm-online.com/fda-mulls-fast-approval-for-unmet-needs-drugs/article/281296/ Fri, 01 Mar 2013 05:00:00 GMT FDA is exploring an alternative drug-approval pathway for drugs intended to address unmet medical needs by "limited use" approvals. MMM The Alabama Supreme Court ruled that a man who claims he was injured by a generic version of Pfizer's Reglan can sue the innovator company. http://www.mmm-online.com/innovator-risks-over-generic-warnings/article/281298/ Fri, 01 Mar 2013 05:00:00 GMT The Alabama Supreme Court ruled that a man who claims he was injured by a generic version of Pfizer's Reglan can sue the innovator company. MMM FDA has never won a First Amendment case, and its string of losses led it to bring this one under false colors http://www.mmm-online.com/as-i-see-it-fda-and-the-first-amendment/article/277305/ Fri, 01 Feb 2013 05:00:00 GMT FDA has never won a First Amendment case, and its string of losses led it to bring this one under false colors MMM FDA commissioner Margaret Hamburg says that if academia, industry, government scientists and regulators could come together more in pre-competitive collaboration it could get more done http://www.mmm-online.com/fda-chief-cites-the-need-for-more-collaboration/article/277308/ Fri, 01 Feb 2013 05:00:00 GMT FDA commissioner Margaret Hamburg says that if academia, industry, government scientists and regulators could come together more in pre-competitive collaboration it could get more done MMM FDA deputy chief counsel for litigation Eric Blumberg told a December conference that "Money is clearly not doing the job...We need to employ a 'bigger hammer,' to send people to jail." http://www.mmm-online.com/use-jail-to-fight-fraud-fda-lawyer/article/277312/ Fri, 01 Feb 2013 05:00:00 GMT FDA deputy chief counsel for litigation Eric Blumberg told a December conference that "Money is clearly not doing the job...We need to employ a 'bigger hammer,' to send people to jail." MMM