Proactive Communication Key to Managing Challenging Regulatory Agencies

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies.  Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance.  In other instances, one investigator can simply prove more difficult than others.

To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives.  Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. Continue reading


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.  Well-managed regulatory intelligence groups 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



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. A successful regulatory affairs operation builds on clear organizational structure, cross-department coordination and strong regulatory agency communication. Continue reading


The Drug Quality and Security Act Works Toward Ensuring Drug Safety

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