Regulatory Roundup: FDA, Arkansas Sign Agreement to Enhance Regulatory Science - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: FDA, Arkansas Sign Agreement to Enhance Regulatory Science

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA released this week a new final guidance for industry, Residual Drug in Transdermal and Related Drug Delivery Systems. The document provides recommendations “to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development—as well as during manufacturing and product lifecycle management—to ensure that the amount of residual drug substance at the end of the labeled use period is minimized.” Because these types of products purposely contain more drug substance than is intended to be delivered to the patient in order to facilitate the medication’s delivery, formulators and manufacturers must use a scientific-based approach to ensure the product’s quality, efficacy, and safety. Specifically, the approach should “ensure that the amount of residual drug substance is minimized consistent with the current state of technology,” says the guidance. The document provides information on achieving this minimization and suggests applying a QbD approach.

FDA has signed an agreement with the state of Arkansas to create a joint center to enhance regulatory science. The memorandum of understanding is part of the agency’s National Center for Toxicological Research (NCTR) and is the first agreement of its kind with NCTR. The framework calls for joint research, educational training, collaborations, and outreach, according to an agency press release. In addition, a joint committee will be formed to help manage the arrangement. NCTR is based in Jefferson, Arkansas, and conducts peer-reviewed research, provides training, and develops novel scientific tools to aid the agency in regulatory decision-making process, according to the announcement.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here