FDA Issues GDUFA Documents

August 27, 2012

FDA Issues GDUFA Documents

The Food and Drug Administration (FDA) has issued five documents to answer questions about the programs requirements and details regarding implantation from industry.  In addition, the documents also include steps human generic drug manufacturers will need to complete to be in compliance with this new legislation.

The following are the GDUFA Documents:

1. Federal Register: Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012

http://www.ofr.gov/OFRUpload/OFRData/2012-20944_PI.pdf

2. Federal Register: Draft Guidance for Industry on Self Identification of Generic Drug facilities, sites and organizations

http://www.ofr.gov/OFRUpload/OFRData/2012-20944_PI.pdf

3. Federal Register: Draft Guidance for Generic Drug User Fee Amendments of 2012

http://www.ofr.gov/OFRUpload/OFRData/2012-20945_PI.pdf

4. Notice of Opportunity to withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations

http://www.ofr.gov/OFRUpload/OFRData/2012-20947_PI.pdf

5.  Agency Information Collection Activities; proposed collection

http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0748-0001

6. Federal Register: Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers

http://www.gpo.gov/fdsys/pkg/FR-2012-08-27/html/2012-20944.htm

7. Notice of Opportunity to Withdraw abbreviated New Drug Applications to Avoid Backlog Fee Obligations

http://www.gpo.gov/fdsys/pkg/FR-2012-08-27/html/2012-20947.htm