Paul Glimcher In a sign of the increasing role real-world evidence (RWE) will have in healthcare research, FDA recently announced a $100 million proposal to build a modern system to gather RWE from about 10 million individuals. The good news is that this could transform clinical trials Powered by WPeMatico Continue reading FDA’s $100 Million Real-World Evidence Project: Making It All It Can Be
Continuing his attack on high drug prices, President Donald Trump and Health and Human Services (HHS) secretary Alex Azar launched a salvo to change how Medicare pays for drugs administered in doctors offices and hospital clinics. A new proposal aims to reduce reimbursement for medicine Powered by WPeMatico Continue reading Pharma Blasts Trump Reference Pricing Proposal
In publishing its proposed rule on disclosing drug prices just three weeks before the November mid-term Congressional elections, it s not a big stretch to regard the move by the Trump administration as designed primarily for short-term political purposes and not to better inform the American p Powered by WPeMatico Continue reading Politics Drives DTC Price Disclosure Rule
In another in a series exploring the use of expedited FDA approval options, Leela Barham looks to see if there is a boost to the speed of FDA approval when a drug not only secures one or more of the FDA s expedited development and review methods, but when they are also designated an orphan dru Powered by WPeMatico Continue reading Does Being an Orphan Speed Up FDA Approval?
President Trump has suggested that the FDA process for drug approval is slow and burdensome. Yet use of the FDAs options for speedier regulatory approval applied to more than half of novel drug approvals in recent years, but just what drugs and from which companies are being approved faste Powered by WPeMatico Continue reading Big Companies Driving FDA Fast Lanes
There s always pressure to get the very best new drugs to patients faster, not only driven by commerce, but because it can make a life or death difference to patients. President Trump in particular has criticized the FDA for a slow and burdensome approval process. Leela Barham takes a look at Powered by WPeMatico Continue reading Take-Up of FDA Fast Lanes
The heritage for introducing faster FDA approvals is to speed up access to treatments that address some of the most serious conditions. With more than half of novel drug approvals by the FDA in the last three years approved using one or more expedited approaches, are the right drugs getting fa Powered by WPeMatico Continue reading Are the Right Drugs Getting Faster FDA Approval?
There s been a lot of talk about speeding up drug approval at FDA, especially from President Trump. So just how fast can approval be? In another in a series to explore the expedited FDA approvals, Leela Barham takes a look at the speed of approval for each of FDA’s expedited development a Powered by WPeMatico Continue reading How Fast are the FDA Fast Lanes?
President Trump in particular has criticized FDA for a slow and burdensome approval process. FDA offers four options to speed up approval and they can be used in combination. But just which of the many combinations offers the fastest approval? Leela Barham takes a look at the combinations used Powered by WPeMatico Continue reading The Fastest Route through FDA
Few regulatory affairs heads would dispute the rising complexity of compliance and regulation in life sciences. Despite efforts to encourage consistency in international submissions, evolving priorities and variances in individual market demands are heaping the pressure on regulatory professio Powered by WPeMatico Continue reading Managing Local Language Regulatory Submissions