Congress, Feds, FDA Take Action to Combat Opioid Crisis

The House recently enacted multiple legislative proposals to support treatment of opioid abusers and deter inappropriate drug prescribing and illegal distribution. This bipartisan action sets the stage for similar action by the Senate, as the legislators seek to address the deadly drug epi Powered by WPeMatico Continue reading Congress, Feds, FDA Take Action to Combat Opioid Crisis

FDA Clears Pathway for Off-Label Economic Communications

After years of debate and discussion, FDA has finalized a more flexible policy for how biopharmaceutical companies may discuss payments, outcomes and healthcare economic data with payers, formulary committees and other audiences with expertise in drug prescribing and coverage. By clarifying a sa Powered by WPeMatico Continue reading FDA Clears Pathway for Off-Label Economic Communications

Regulatory Information Management: Current and Future States

At this month’s AMPLEXOR Life Sciences Be The Expert conference in Dubrovnik, Croatia, Steve Gens of life sciences consultancy Gens & Associates talked about the evolution of Regulatory Information Management (RIM) and offered some predictions for 2022. Pharm Exec caught up Powered by WPeMatico Continue reading Regulatory Information Management: Current and Future States

Digital Health: Regulatory, Compliance, and Legal Challenges

At this month’s AMPLEXOR Life Sciences Be The Expert conference in Dubrovnik, Croatia, Ilyssa Levins, president and founder of the Center for Communication Compliance , talked about some of the regulatory, compliance and legal challenges posed by the digital health revolutio Powered by WPeMatico Continue reading Digital Health: Regulatory, Compliance, and Legal Challenges

Piecing Together the Pricing Puzzle: The Midterm Elections

There is no magic bullet that will dramatically impact drug pricing to everybody s liking patients, industry, and government. But a stepwise approach involving a series of changes, including taking advantage of the next midterm elections, could point the path toward a solution Powered by WPeMatico Continue reading Piecing Together the Pricing Puzzle: The Midterm Elections

Why It s Time to Get Smarter about Content Management and Document Production

In other industries with complex information and document needs, such as aerospace engineering, creating smarter documents populated with pre-approved information components is accepted practice. Yet up to now structured authoring is an approach that has eluded life sciences, limiting firms a Powered by WPeMatico Continue reading Why It s Time to Get Smarter about Content Management and Document Production

Improving Regulatory Resource Management through Systematic Measurement

As submissions complexity intensifies, life sciences firms are finding that the key to better resource management is better measurement, writes Adrian Leibert. Regulatory demands in the life sciences world are not only increasing in volume and complexity; submissions workloads are also Powered by WPeMatico Continue reading Improving Regulatory Resource Management through Systematic Measurement

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

After months of expectations and repeated delays, President Donald Trump formally announced his strategy for making prescription medicines more affordable and accessible in the U.S. Trump promised to take on the tangled web of special interests that drive up drug prices, noting the high amount Powered by WPeMatico Continue reading Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With