- Adult Immunization
- Hepatology
- Pediatric Immunization
- Screening
- Psychiatry
- Allergy
- Women's Health
- Cardiology
- Pediatrics
- Dermatology
- Endocrinology
- Pain Management
- Gastroenterology
- Geriatrics
- Infectious Disease
- Obesity Medicine
- Rheumatology
- Oncology
- Nephrology
- Neurology
- Pulmonology
Drug Safety, Post-FDA Approval: What to Look For
What characteristics of new drugs might help predict safety issues years later? Find answers and tips on what classes to watch.
At least 1 new safety issue was detected in the years after FDA approval in 1 of every 3 novel therapeutics that received approval during a recent decade. Four therapeutic areas were affected by classwide safety communications between 2006 and 2015: triptans, phosphodiesterase-5 inhibitors, bisphosphonates, and dipeptidyl 4 peptidase inhibitors.Researchers conducted a cohort study of novel therapeutics approved between 2001 and 2010 to determine the frequency of postmarket safety events: withdrawals because of safety concerns, issuance of boxed warnings, and issuance of safety communications.They also wanted to find out whether any novel therapeutic characteristics known at the time of approval-drug class, therapeutic area, priority review, accelerated approval, orphan status, nearâregulatory deadline approval, and regulatory review time-were associated with increased risk.Click on the slides above for highlights of their findings and conclusions.  Reference:Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317(18):1854-1863.Â
Centralizing evidence to boost efficiency across life sciences functions
May 28th 2025The life sciences industry is growing as medtech, biopharma, and investors all face an era of unprecedented innovation and potential. However, firms are also preparing as much as possible for unexpected business challenges and the likelihood of volatility. In an industry that must balance profitability with product efficacy, many life sciences firms are working with new efficiencies to bolster research. In this whitepaper from Wolters Kluwer, you will learn how centralized, unified, and coordinated resources can help organizations overcome fragmented processes and miscommunications, leading to enhanced problem-solving and collaboration, as well as improved outcomes.
