New FDA Guidance on Completeness Assessements for Type II API Drug Master Files

Since 1st October 2012, special regulations have been applying to the US Type II Drug Master Files. This year in February, the FDA published a new Guidance for Industry. Read here what the DMF holder has to consider when submitting data about the API Drug Master File.,15339,S-WKS_n.html

Since the coming into force of the “Generic Drug User Fee Act” (GDUFA) on 1st October 2012, special regulations have been applying to the submission to the FDA of a Drug Master Files for a pharmaceutical API (Type II DMF). The DMF holder must pay a one-time fee when authorising the reference of his/ her DMF in an application for a generic drug (Abbreviated New Drug Application, ANDA). Moreover, the DMF will undergo a completeness assessment through the FDA.

This year in February, the FDA published a Guidance for Industry entitled “Completeness Assessments for Type II API DMFs under GDUFA” which provides DMF holders with comprehensive information regarding the application for a Type II DMF. The document describes the criteria according to which the FDA performs a completeness assessment and which data are expected.

This completeness assessment does not replace the full scientific assessment to be executed at a later time. It serves to find out whether the data contained in the DMF are sufficient for the ANDA. In a completeness assessment, the following elements are examined:

  • Is the DMF active?
  • Has the fee been paid?
  • Has the DMF been previously reviewed?
  • Does the DMF pertain to a single API?
  • Does the DMF contain certain administrative information?
  • Does the DMF contain all the information necessary to enable a scientific review?
  • Is the DMF written in English?

The Guidance contains a checklist (Appendix 1) listing the criteria according to which the FDA performs the assessment. For the DMF holder, this list is helpful to check the completeness of his/ her data before submitting them to the FDA.

One essential element underlined in this Guidance is to pay the DMF fee in due time (at least 6 months prior to the submission of an ANDA). The FDA won’t continue to process the DMF as long as the fee hasn’t been paid. If the applicant of an ANDA references in his dossier a DMF for which a fee is due, the FDA will inform him. If the fee hasn’t been paid within 20 days after notification, the FDA will stop the further processing of the application.

When submitting a DMF, the form “FDA 3794″ (Generic Drug User Fee Cover Sheet) should be attached. It contains the minimum information required by the FDA to determine whether the DMF holder has satisfied his fee obligations.

After the successful completeness assessment of a DMF, a number will be attributed and posted on a publicly available API DMF list. The FDA has compiled all important information regarding DMFs Type I-V on the Drug Master File webpage. Here, you can also find the list of all active DMFs.

//////API Drug Master File, fda, type2



DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

One thought on “New FDA Guidance on Completeness Assessements for Type II API Drug Master Files”

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s