regulatory landscape

8.18.2014 Compliance

Document Like the Romans: Maintaining Regulatory Knowledge

By Jacob Presson, Senior Research Analyst If anything could be said about the ancient Romans, aside from their insatiable drive for conquest and glory, it was their proclivity for documenting everything that happened around them.  The fact that...
 

3.6.2014 Clinical Development

Using Per-Patient Visit as Basis to Compensate Investigators

By Yanis Saradjian, Director of Consulting There is a strong push from regulators worldwide for pharmaceutical companies to first report and then justify physician payments. This push includes all compensation for activities such as scientific speaking,...
 

2.4.2014 Clinical Development

Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

By Sarah Ray, Research Analyst Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the...
 

1.22.2014 Regulatory Affairs

The Regulatory Hokey Pokey

By Jacob Presson, Research Analyst Many readers will be familiar with the children’s dance song “The Hokey Pokey” (or “Hokey Cokey” for our UK-based readership) which instructs participants to, “put your right arm in, put your right...
 

1.20.2014 Regulatory Affairs

Three Steps Toward a Successful Regulatory Affairs Operation

By Jacob Presson, Research Analyst As regulatory affairs groups in the pharma industry continue their shift into more strategic roles with greater influence on product development, it is vital that these groups are structured efficiently and communicate...
 

12.18.2013 Fair-Market Value

Watch Your Service Fees So That CMS Doesn’t Have To

By Jacob Presson, Research Analyst After the Sunshine Act was released and a Final Rule was issued in early 2013, pharmaceutical companies geared up to make sure that their reporting and disclosure systems were in good working order.  Determining...
 

11.26.2013 Drug Safety

Improving Drug Safety: The Drug Quality and Security Act

By Sarah Ray, Research Analyst Recent events have highlighted the need for increased government regulations to uphold the pharmaceutical supply chain and improve existing drug safety measures. Since the contamination of steroidal injections in 2012...
 

10.23.2013 Sales

‘Customer-Centric’ Sales Strategies: How Will This Benefit Pharma?

By Christie Shilling, Research Analyst The latest buzzword among pharma sales management is “customer-centric.”  Especially with the Sunshine Act legislation having finally been implemented, companies are looking for any way to remodel their...
 

9.24.2013 Marketing

New Mobile Health Application Guidelines: The Regulatory Impact on Developers

By Natalie DeMasi, Research Analyst If it looks like a medical device and it works like a medical device, it’s probably a medical device. App developers, the wait is over!  The FDA has finally released its guidance on mobile medical applications. ...
 

8.29.2013 Regulatory Affairs

The [Regulatory] Times, They Are A-Changin’

By Jacob Presson, Research Analyst Regulatory affairs groups in the pharmaceutical industry have been going through a fast-paced evolution over the past 10 years.  It wasn’t that long ago that these groups were almost taken for granted in the...