Developing, refining and coordinating a complex pharmaceutical launch sequence can be a significant challenge for even large global groups. There are a myriad of market considerations on top of commercial priorities that come into play when setting the launch sequence. Bringing a strategic regulatory affairs function into these discussions is also key in order to keep the license cascade in line with the proposed launch sequence. Continue reading
Developing competitive rates, to recruit key industry experts has never been the easiest of tasks for life sciences companies. Add in the additional complexity associated with Sunshine Act reporting requirements and the recruitment process become even more difficult. In this heightened regulatory environment, recruiting top-tier physicians and other thought leader types means that companies must balance their desire to remain competitive with adhering to rates that do not fall too far astray of physician fair-market values. Continue reading
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
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, journal publications and clinical trial operations. Authorities are looking for greater transparency, and that starts with fair-market value reporting. But for the most part, life science companies have been left without concrete guidance on how to calculate fair-market value for investigator compensation. Continue reading
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 AllTrials initiative, many companies are determined to become proactive when it comes to data disclosure.
Over the past decade, various patient advocacy and regulatory clinical data stakeholders have pushed for greater transparency. Under the FDA Amendments Act of 2007, companies in the US have until 21 days after the first patient is enrolled to register their clinical trial on ClinicalTrials.gov. These teams also have up to one year after their clinical trials conclude to post results. More recently, in Europe, the EMA released an updated version of the European Clinical Trials Database (EudraCT) which aligns its summary results with those already found on ClinicalTrials.gov. Continue reading
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
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
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 fair-market value (FMV) for services provided is an ongoing effort. Continue reading
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
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. The mobile medical applications guidance describes the types of apps that are covered under FDA oversight and those left to the discretion of app developers. Continue reading