FDA Releases Draft Guidance on ANDA Submissions - - BioPharm International

ADVERTISEMENT

FDA Releases Draft Guidance on ANDA Submissions


FDA has released draft guidance on the content and format of abbreviated new drug applications (ANDAs) to assist in the preparation of ANDAs submitted to FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

The draft guidance outlines the requirements for each section of the Common Technical Document (CTD) format for product applications and identifies supporting guidance documents and recommendations issued by FDA to assist in preparing the submission. Information on what an applicant should include to ensure a complete, high-quality application is presented. Previously published guidance has been published by FDA on the filing process, including the refuse-to-receive standards.

The fee structure or payment of obligations under the Generic Drug User Fee Amendments (GDUFA), the submission and assessment of drug master files (DMFs), amendments to original ANDAs and changes being effected, or prior approval supplements are not addressed in the draft guidance.

Source: FDA.gov

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines

Click here