January 15, 2016
The U.S. Food and Drug Administration today issued draft Guidance for Industry #238: Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. GFI #238 provides recommendations for chemistry, manufacturing, and controls (CMC) and pharmacokinetic information required for the approval of modified release veterinary parenteral drug products.
Animal drug product specifications need to be established in a way that ensures every batch results in the therapeutic benefits listed on the product label. Draft guidance #238 includes recommendations on:
- Development of an in vitro drug release test method
- Components of a drug release method
- The role of an in vivo/in vitro correlation (IVIVC) or an in vivo/in vitro relationship (IVIVR) in a product application
- Methods for establishing IVIVC/R for a parenteral product
- Establishing clinically relevant in vitro drug release specifications
- Methods for using in vitro product specifications for setting expiry and for supporting batch release
- Filing information for in vitro drug release methods and data as well as material for the Pharmaceutical Development Report, and Chemistry, Manufacturing, and Controls technical section for modified-release parenteral dosage forms.
This draft guidance is applicable to both new animal drug applications and abbreviated new animal drug applications.
The FDA is accepting public comments on this draft guidance beginning on January 19, 2016. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2015-N-4563 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 60 days after the notice of availability of this guidance publishes in the Federal Register. While comments are welcome at any time, you should submit them by the closing date to ensure FDA considers your comments in drafting the final guidance.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2015-N-4563 on each page of your written comments.
The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852