Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There's been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.
On May 11, Scott Gottlieb, M.D., officially became the 23rd commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb has previous FDA experience, having served as deputy commissioner for medical and scientific affairs, among other positions, during the George W. Bush administration.
According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.
IPR provides an adversarial process for challenging patents at the U.S. Patent Office. As of earlier this year, there were over 50 IPR petitions reportedly on file challenging patents relating to the large molecule biopharma space.
New regulatory developments at the FDA and beyond allow companies to leverage patient experiences and behaviors to create better products, obtain faster regulatory approvals, and better demonstrate the value of their products over time to payers and reimbursement bodies.
Learn how the Cures Act is changing the pathways and processes for developing and getting approval for new drugs and devices and new uses for existing products.
Although good auditors base conclusions on facts, emotions will play an important role in how they perceive your company, your leadership, and your quality culture. This is not a precise process, and cultural differences can often sabotage good intent.
The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times.
Genentech has garnered 15 Breakthrough Therapy Designations for its medicines since 2013, which is more than any other company. Jeffrey Siegel, senior group medical director for Genentech, believes this success reflects the company’s focus on developing new approaches to address unmet medical needs.
Trade tariffs can significantly impact the cost of importing and exporting investigational products and ancillary supplies for clinical trials. As such, it is important that companies consider harmonized tariff classification to ensure no money is left on the table.