September 6th 2024
Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.
Optimizing the Review Process for Promotional Content
January 10th 2022As the pressure on teams reviewing promotional content has increases, both in terms of volumes of content and complexity, Sameer Lal discusses the need for a near-term strategies using artificial intelligence (AI) and machine learning (ML) to decongest bottlenecks of the manual review process.
The Drug Supply Chain Security Act Deadline is Sooner Than You Think
December 1st 2021The 2013 Drug Supply Chain Security Act (DSCSA) established a framework for exchanging data when products are transacted throughout the US pharma supply chain. Its goal, by November 2023, is to enable unit-level traceability in a secure, interoperable manner. HDA’s Chip Davis talks about how pharma manufacturers must prepare for this implementation deadline.
Why Pharma’s Approach to IDMP Today Will Matter to Patients & Physicians Tomorrow
November 15th 2021The Identification of Medicinal Products (IDMP) software industry has talked up the broader potential of data-driven processes. Pharma companies and their software providers have an important role to play in realizing these processes. Frits Stulp discusses the foundations that need to be laid for lasting transformation of pharma information access in the real world.
FDA Highlights Value and Challenges of Advanced Drug Manufacturing
October 21st 2021FDA is expanding its Emerging Technology Program (ETP) and providing more support for new drug applications (NDAs) that present advanced manufacturing technologies, but the agency and industry face key challenges in advancing these initiatives.