Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after one round of revision and comments on the original draft published in 2014. With this document, titled "Qualification Process for Drug...
Product Development
The CDERDirect NextGen Collaboration Portal
Rapid and secure communication with the FDA is an essential task within the regulated industry, and CDER makes some communications easier through the NextGen Collaboration portal. This tool is part of the FDA's efforts to streamline and modernize the drug development...
Strategic Planning for Medical Products
Part 1 - US Pharmaceutical Regulatory PathPharmaceuticals and medical devices are regulated in the USA by the FDA. The regulations started to diverge in 1976 following the passage of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Each type of...
Medical Device Development
Part 1 – Medical Device DesignJune is our month to examine how new medical devices are approved. In this 4-part series we’ll focus on FDA regulatory pathways, although much of what we discuss can be applied in other jurisdictions. Global harmonization of device...
New Medicine Development
Part 1 - DiscoveryMay is our month to review how new medicines are developed. This will be an eight part series describing the different stages of drug development which are applicable in all regulatory jurisdictions.The aim of discovery research is to clearly...
Device Submissions Are Now All Electronic
eSubmitter Tool In December, the FDA issued a final rule revising all the regulations for medical device regulatory submissions to replace paper with electronic copies. An update to the eCopy Guidance was issued with the rule, along with updates to guidance on...
Setting Drug Expiration Dates
Have you ever wondered how the expiration date is determined for a pharmaceutical product you’ve used? Whether prescription or over the counter, all medications have their expiration dates determined through a stability program in which batches of the product are held...
Standards Organizations Play a Role in Medical Product Regulation
Regulatory bodies worldwide make use of consensus standards developed by independent organizations to establish best practices and conceptual harmony on specialized areas of expertise. Standards organizations for drugs include the regional Pharmacopeia USP, EP, and JP...