FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance

FDA published the draft guidance for industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, in the Federal Register Aug. 27. The publication provides answers to questions submitted during the public comment period on the draft stability guidance that was published on Sept. 25, 2012. The final guidance for industry was published on June 20, 2013. The question-and-answer document is open for comment for the next 60 days.

FDA’s stability guidance for generic drugs recommends that the generic-drug industry follow ICH stability-related guidance. The question-and-answer guidance clarifies the effect of the stability guidance on drug master file holders, discusses questions related to manufacturing and packaging, offers recommendations for amendments to pending abbreviated new drug applications, and answers other questions about stability studies.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here