Social Media Raise Concerns for Marketers, Trial Sponsors
March 12th 2014While biopharmaceutical companies are using websites and third-party postings to provide information on medical products - despite a host of regulatory issues - social media use is in its infancy related to the design and conduct of clinical trials.
ACA Rollout Raises Ante for Patient Access and Assistance
March 11th 2014Amid the looming March 31 deadline for remaining uninsured and underinsured Americans to purchase health insurance mandated by the Affordable Care Act (6 million newly Medicaid-eligible individuals are expected to enroll), pharmaceutical manufacturers and other key players in this space are emphasizing the importance of enhancing access to medications for the now rapidly expanding patient base.
"Close Call" for American Rx Marketers on Medicare Part D
March 11th 2014As the U.S. heads towards a public market place in which Medicare, Medicaid, CHIPs, VA, and now Obamacare will shortly comprise almost 70% of the American healthcare market, American Rx marketers recently endured a “close call” with the U.S. Department of Health and Human Services over the arbitrary deletion of dozens of key drugs from a major American public Rx platform – Medicare Part D.
Unlock The True Value of Digital Communication: Knowledge, Motivation, Context
March 6th 2014Interaction between pharma representatives and doctors has traditionally been a paper-based and static experience in which the representative enters with one-quarter of a campaign in hand and then tries to deliver the remaining pieces three more times through the year.
Track-and-Trace Not Enough to Halt Drug Counterfeiters
March 4th 2014Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight.
Changing the Hepatitis C Treatment Landscape
February 27th 2014Widespread screening, along with new therapies that move patients from a chronic condition to a cure, is changing the landscape in treatment of hepatitis C, says an expert panel recently convened by the American Journal of Managed Care (AJMC).
New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman
February 25th 2014When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process for generic drugs, and combat the agency’s backlog of drug applications.
Ranbaxy Suspends Shipments, Addresses Quality and Integrity Problems
February 24th 2014Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
Industry Takes EU to Task Over Pharmacovigilance Fees
February 21st 2014Europe’s main pharma industry bodies - EFPIA, EGA, EuropaBio, AESGP and EUCOPE - have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010?.