Pearls of Wisdom
FDA aims to revamp 510(k) program, emphasizing modernization
The current 510(k) regulatory review pathway for medical devices is poised for a significant overhaul, the U.S. Food and Drug Administration (FDA) announced this week. The proposal making the most headlines is that FDA aims to shift the industry towards...
Experienced Quality and Regulatory leader joins Pearl Pathways
Pearl Pathways announces the hiring of Beckinam Nowatzke as a Quality Assurance and Regulatory Affairs (QA/RA) Advisor. Nowatzke brings over 17 years of experience across biotechnology, pharmaceutical, CRO, and medical device industries.An accomplished...
Just tell me what hoops to jump through to get my drug approved. What? Somebody already did?
Many people working in drug development have expressed the frustrated wish that regulators would just go ahead and tell them exactly what they must do in order to move their drug through the development and approval process. The level of exasperation with...
FDA sets new record for generic drug approvals in October
The United States Food and Drug Administration (FDA) set a new record for generic drug approvals in October 2018, RAPS reports. The new number to beat is 128. The 128-total comprised of 110 approvals and 18 tentative approvals, and also included 23 first...
FDA In Your Future? Robert Seevers will lead Purdue Foundry event on November 8
Are you developing a biopharmaceutical, device, or diagnostic that requires FDA approval? If so, the pathway towards regulatory approval often commences with a Pre-IND or Pre-Submission meeting. Purdue Foundry will host Robert Seevers, PhD, a Senior...