Most Recent Articles by James G. Dickinson
The number of new industry-sponsored clinical trial starts went up 12% to a record high in 2007, according to data released by Parexel International Corp.
An HHS Office of Inspector General report says the FDA does not approve 96% of new generic drugs reviewed during their first cycle because they contain chemistry deficiencies.
DDMAC responses to queries posed by drug sponsors or manufacturers regarding ad/promo issues may only be regarded as official (for legal purposes) if they are received in letter form, the division's director, Thomas Abrams says.
In a ruling that provided comfort to drug companies defending dissident former employees' whistleblower suits, the US Supreme Court said in June that False Claims Act liability is limited to acts done with an intent that the government itself pay a false claim.
Calling it "a tremendous loss for the agency," FDA commissioner Andrew von Eschenbach announced in June that the impending departure after three years in the job of the agency's top enforcement officer.
More Articles by James G. Dickinson
Investment in healthcare IT stands at an all-time high. The government has spent billions to promote EHR adoption. Yet the physician wish list is a mile long, while hospitals and patients are not where they need to be. To peel back the layers of what we've all been waiting for in the Great Data Capture of the 21st Century, and to review the changes enabling the healthcare data ecosystem to coexist, MM&M presents this e-Book. Click here.
- Insurance trade group says new HCV drugs could cost California billions
- FDA advisory panelists describe decision to recommend approval of "female Viagra"
- Five things for pharma marketers to know: Tuesday, July 7
- Curious if you're a finalist in the MM&M Awards? Find out now
- Vertex's Orkambi nabs FDA approval but may face payer backlash
What does going "beyond the pill" actually mean? At MM&M's recent inaugural spring conference, audience members heard from real-world companies that are managing the organizational, technological, and promotional challenges inherent in this transition, such as partnering with health neophytes, harnessing technologies that allow deeper engagement with patients, and adopting a new commercial mindset to serve, not sell. Download here.