The Obama Administration, seeking to expand international trade, negotiated the Trans-Pacific Partnership (TPP) with 11 other Pacific Rim countries. After President Trump assumed office in January, he immediately withdrew the U.S. from the multilateral agreement. The other TPP countries — now known as the TPP 11 — and other Asian countries have since been seeking a replacement low-tariff trade market.
FDA Commissioner Scott Gottlieb has taken the wheel at an exciting time, when insights from genomics are starting to come to fruition and promising new therapies based on new technologies are being developed. This article explores some of the policy changes happening now in the regulatory rare disease space — and shifts we expect to see in the future — as the FDA’s leadership team implements these changes at the agency.
When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry.
For the Drug Supply Chain Security Act to be effective, it requires pharma to institute electronic, interoperable systems that enable stakeholders to identify and trace drugs distributed into the U.S.
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.