FDA Releases Draft Guidance on ANDA Submissions - - BioPharm International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FDA Releases Draft Guidance on ANDA Submissions


FDA has released draft guidance on the content and format of abbreviated new drug applications (ANDAs) to assist in the preparation of ANDAs submitted to FDA under section 505(j) of the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The draft guidance outlines the requirements for each section of the Common Technical Document (CTD) format for product applications and identifies supporting guidance documents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(DMFs), amendments to original ANDAs and changes being effected, or prior approval supplements are not addressed in the draft guidance.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

Merck KGaA Announces Acquisition of Sigma-Aldrich for $17 Billion
September 22, 2014
Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
GSK Fined in China Bribery Scandal
September 19, 2014
GPhA Supports Restricted Access Bill
September 18, 2014
Author Guidelines

Click here