Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued
Who would have thought when we completed work on the first submission for which we ever authored 3 or more documents and provided strategic support (our criteria for saying that we supported a client’s submission), that we’d be celebrating our 300th such submission just 12 years later. From that humble beginning, we’ve now supported more … Continued
The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization. ICER’s mission is to conduct evidence-based reviews of healthcare interventions that help guide patients, doctors, and payers to high-value, cost-effective treatments using rigorous, transparent methods. ICER was founded in 2006 by Steve Pearson, a former fellow at the Americas Health … Continued
What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The … Continued
The regulatory landscape for drugs to treat rare diseases is being disrupted. Gleaning from several recent health authority advisory committee deliberations have provided a glimpse into the science and complexity of new drug development for rare diseases. Health authorities, drug developers, and key opinion leaders alike struggle to attribute meaningful data signals in clinical studies … Continued
The recent Alzheimer’s Association International Conference (AAIC) meeting was a testament to the thriving landscape of Alzheimer’s research, drawing over 7,000 in-person and 4,000 virtual attendees. One standout moment was the presentation of a successful Phase 3 trial for Donanemab, an amyloid beta targeting antibody, which was hailed as a “historic watershed” in the field. … Continued
On 2022年8月16日, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law. One key objective of the IRA is to shift healthcare costs from patients and the Centers for Medicare & Medicaid Services (CMS) to health insurers and pharmaceutical manufacturers. While the provisions allowing CMS to negotiate drug prices for select … Continued
As a pharmacologist, I’ve always been curious about how drugs work. A favorite time-killer while waiting at a doctor’s office is reading drug labels (also known as package inserts) contained within the pages of “lifestyle” magazines. Ever wonder what a package insert looks like? Ask a pharmacist. By law, pharmacies are supposed to offer that … Continued
Adverse effects of drugs pose potential harm to patients and can hinder or halt the development and intended therapeutic use of a drug. Such effects can arise from primary pharmacology (‘exaggerated pharmacology’, or unintended effects in non-targeted organ systems), secondary pharmacology (i.e., at another receptor, related or unrelated to the primary target), or from the … Continued
In a captivating webinar led by industry experts, Dr. Swati Jaiswal, Senior PBPK Consultant at Certara, and Dr. Erica Winter, Director of Clinical Pharmacology at EQRx, Model-Informed Formulation Development (MIFD) took center stage. The session provided valuable insights into the strategic utilization of model-informed approaches in drug development projects. A compelling case study on development … Continued
