Signal Detection: The Key to a Sound Pharmacovigilance Strategy

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Thanks to a mixture of recent regulations and negative media coverage, pharmacovigilance remains a hot topic across the life sciences industry. Pharmas, biotechs and device companies alike continue to take an active interest in leveraging new technologies to uncover, assess and mitigate safety concerns associated with the products they develop.  For example, in an effort to streamline the adverse event reporting process, several teams — surveyed for a recent Cutting Edge Information study — have established strong, external-facing social media platforms. Still other organizations have instituted customized adverse event databases to help them track and analyze the adverse event reports that their dedicated teams receive. Continue reading


Document Like the Romans: Maintaining Regulatory Knowledge

Jacob Presson, pharmaceutical market access researcher
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 we know so much about the Romans comes down to the sheer level of documentation that survives from their time.  When pharmaceutical companies are looking at their own documentation priorities, preserving regulatory knowledge and the associated protocols should be close to the top of the list. Continue reading


Manage Regulatory Intelligence Groups to Stay Ahead of New Regulatory Guidelines

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

The rapid pace that regulatory guidelines are updated around the world can be dizzying for even some large and established regulatory affairs groups to keep up with.  A well-managed regulatory intelligence group brings many advantages to companies, whether operating on a small scale domestically or on a large scale internationally.  Regulatory intelligence can provide vital support to companies both pre- and post-launch. Continue reading


Pharma Companies Increase Cross-Functional Communication with Regulatory Affairs Teams

The last 10 years have seen regulatory affairs groups evolve from a group focused on submitting new drug applications and coordinating communication with regulatory agencies.   Regulatory groups now expect to have a much greater strategic influence on the clinical development process, as well as provide commercial and medical input for various teams throughout the organization.  Regularly, internal cross-functional communication, especially with clinical and R&D teams, empowers regulatory affairs to more significantly impact product development.  Allowing regulatory affairs some input when discussing product pipelines also generates more effective trial designs that meet regulatory agencies demands — inevitably saving companies time and money. Continue reading


The Regulatory Hokey Pokey

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

Many readers will be familiar with the childrens 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 arm out.” Little did the originators of this song and dance know, but “The Hokey Pokey” contains a valuable message for regulatory affairs groups. Continue reading


Three Steps Toward a Successful Regulatory Affairs Operation

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior 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 well both internally and externally. Successful regulatory groups build on clear organizational structure, cross-department coordination and strong regulatory agency communication. Continue reading


Improving Drug Safety: The Drug Quality and Security Act

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior 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 — which led to over 750 cases of fungal meningitis — ensuring drug safety has been top priority within the pharma industry and for legislators alike. More specifically, the FDA has sought to increase its oversight on compounding facilities. While the FDA regulates pharmaceutical companies, compounding pharmacies are subject to rules created by individual state boards of pharmacy. Continue reading


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 industry.  Recently, however, this role has been changing substantially from simply getting a drug approved to being involved much earlier in the development process and asked to significantly influence the final product. Continue reading



The Debate on ‘Pay-for-Delay’ and Anti-Trust Laws


By Jennifer Harrell,
Research Analyst

“Pay-for-delay” deals face increasing regulatory scrutiny, although the details of their true economic implications remain murky. These deals – often the result of painstaking litigation – allow branded drug makers to maintain market exclusivity by compensating generics manufacturers for later entry dates. Critics of these settlements argue that they deter market competition, burdening the consumer with higher drug prices. The Federal Trade Commission reports that these settlements cost consumers up to $3.5 billion in inflated prices last year. Industry leaders counter that the agreements actually save patients money because generics reach the market more quickly.  According to a recent Cutting Edge Information study, 18% of surveyed companies use pay-for-delay settlements as an exclusivity extension tactic. However, this statistic may be watered down by the off-putting public opinion ramifications, as these agreements are quickly tagged as anticompetitive. Continue reading