by Avery Zimmerman | Jan 31, 2019 | Blog
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
by Avery Zimmerman | Jan 3, 2019 | Blog
In the early 2000s, I sat in an undergraduate microbiology lab and caught the bug. It was not a laboratory-acquired infection, but inspiration from a world only seen under the microscope. The order and the vast unknown was intriguing, leading me to expand my...
by Avery Zimmerman | Jul 26, 2018 | Blog
Last month, the Federal Food, Drug, and Cosmetic Act (FDCA) turned 80 years old. On June 25, 1938, the FDCA was signed by President Franklin Roosevelt. It was passed by the 75th Congress as Public Law 75-717, 52 STAT 1040 to prohibit the movement of adulterated and...
by Avery Zimmerman | Jun 28, 2018 | Blog
There are currently more than 70 approved Risk Evaluation and Mitigation Strategies (REMS) in the Food and Drug Administration (FDA) database. These structured programs are designed with specific goals to ensure that the benefits of drugs outweigh risks, while also...
by curtis@digitalliance.com | May 31, 2018 | Blog
The size of the global pharmaceutical market will reach $1.12 trillion by the year 2022, according to Pharmaceutical Commerce. Yet, many questions linger about what the future of drug development will look like, including technology that will impact the industry and...