News & Insights
Overview of FDA timelines associated with Traditional 510(k)s
Introduction The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking…
What is Drug Development Tool Qualification? Is it Part of the Critical Path?
A new guidance from FDA last month may be adding to confusion in industry regarding the difference between FDA requirements and programs that are voluntary. At first glance, the title "Qualification Process for Drug Development Tools" might suggest that the FDA has new expectations for sponsors planning…
Medical Device Breakthrough Designation
With Centers for Medicare and Medicaid Services (CMS) now offering an add-on payment route for breakthrough designated medical devices, it is anticipated that more companies will be submitting requests to FDA for breakthrough designation status. To qualify for breakthrough designation as defined in…
COVID-19 Vaccine Cold Chain Management Compliance Considerations
With the advent of Coronavirus (COVID-19) disease as a public health emergency, and the development of novel vaccine candidates, addressing the challenges of cold chain management for storage and distribution will be critical. While vaccines typically require similar transport and storage controls, some…
A Valuable Research Tool
The FDA Purple Book Database: A Valuable Research Tool So, what exactly is the FDA Purple Book Database? First a few things it is not:a book purpleThe Purple Book Database is a list (downloadable or searchable on-line at https://purplebooksearch.fda.gov/ ) of all FDA approved biological products…
AstraZeneca’s Trial Is on Hold. It’s a Sign that the Science Is Working
Everyone awaiting a vaccine against Covid-19 must understand this fact: Bad outcomes may happen in vaccine trials. The good news is the U.S. Food and Drug Administration evaluates these outcomes before approving a vaccine. The purpose of clinical trials is to discover what can go wrong with a vaccine…
FDA Is Holding Virtual Panel Meetings for Medical Devices
Due to COVID-19, FDA/CDRH is beginning to hold virtual panel meetings for medical devices. On Sept 8-9, 2020, the Orthopaedic and Rehabilitation Devices Panel will meet to discuss the classification of several pre-amendment devices including: facet screws systems, semi-constrained toe (metatarsophalangeal)…
FDA issues COVID-19 Vaccine Guidance
On June 30, 2020 FDA issued a new guidance on Development and Licensure of Vaccines to Prevent COVID-19. The guidance sets regulatory expectations for the manufacture, non-clinical, clinical and post-licensure use of the vaccine(s). While the agency is cognizant of the urgent need for a COVID-19 vaccine…
Antibody-Dependent Enhancement Risk for SARS-CoV-2 Vaccine Developers
This article explores a phenomenon called Antibody-Dependent Enhancement (ADE). This occurs when binding of a virus to non-neutralizing antibodies enhances its entry into host cells, and sometimes also its replication. The clinical outcome in individuals where an immune response results in the production…
Pre-IND Meeting Requests for COVID-19 Products
Given the numerous inquiries from prospective sponsors interested in conducting clinical trials for COVID-19 products, FDA has issued new guidance to assist sponsors in preparing Type B pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs and biologics1. This…