This presentation is based on the regulatory requirement of new drugs in the USA.

2. Drug master file system in USA
Types of DMF.
IND application in USA.
IND submission process.
New drug application (NDA) in USA
References

3. A Drug Master File (DMF) is a submission to the Food and Drug
Administration (FDA) that may be used to provide confidential
detailed information about facilities, processes, or articles used in
the manufacturing, processing, packaging, and storing of one or
more human drugs.
The submission of a DMF is not required by law or FDA
regulation.
A DMF is submitted solely at the discretion of the holder.
The information contained in the DMF may be used to support an
Investigational New Drug Application (IND), a New Drug Application
(NDA), an Abbreviated New Drug Application (ANDA), another DMF,
an Export Application, or amendments and supplements to any of these.

4. There are five types of DMF's:
Type I Manufacturing Site, Facilities,
Operating Procedures, and Personnel
Type II Drug Substance, Drug Substance
Intermediate, and Material Used in Their
Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or
Material Used in Their Preparation
Type V FDA accepted reference information.

5. Each DMF submission should contain a transmittal letter,
administrative information about the submission, and the specific
information to be included in the DMF.
The DMF must be in the English language. Whenever a submission
contains information in another language, an accurate certified
English translation must also be included.
Each page of each copy of the DMF should be dated and
consecutively numbered. An updated table of contents should be
included with each submission to the USFDA.

6. The investigational new drug applications (INDs) submitted to the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation and
Research (CBER) in USA.
The content & format of IND application is laid out in 21CFR part 312
The IND is also the vehicle through which a sponsor advances to the next
stage of drug development known as clinical trials (human trials).
The investigational new drug (IND) application is the result of a successful
preclinical development program.

7. Cover sheet (FORM FDA 1571)
Table of contents
Introductory statement and a general investigational plan
Investigators brochure
Protocols
Chemistry , manufacturing and control information
Pharmacology and Toxicology information
Previous human experience with the investigational drug
Other relevant information like no. of IND submissions.
Number of copies to be submitted (1 + 2)
Protocol amendments, any changes in the protocol.

8. Applicant / drug sponsor
IND REVIEW BY
CDER
CHEMISTRY PHARMACOLOGICAL Statistical
Safety review
Safety review
accepted
Complete review
Review complete &
acceptable
No deficiencies
Sponsor submits new
data
Clinical
hold
decision
Notify sponsor
Sponsor notified of
deficiencies
Study
ongoing
MEDICAL
Flow chart
process of IND

9. The NDA application is the vehicle through
which drug sponsors formally propose that
the FDA approve a new pharmaceutical for
sale and marketing in the U.S.
The data gathered during the animal studies
and human clinical trials of an Investigational
New Drug (IND) become part of the NDA.

10. Whether the methods used in manufacturing the drug and the
controls used to maintain the drug's quality are adequate to
preserve the drug's identity, strength, quality, and purity.
Whether the drug's proposed labeling (package insert)
is appropriate.
Whether the drug is safe and effective in its proposed
use.

11. Form FDA-356h. Application to market a new
drug, biological or an antibiotic drug for human
use.
Form FDA 3397. User fee cover sheet.
Form FDA 3331. New drug application field report.

13.  Fda.gov. 2019 [cited 1 February 2019]. Available from:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor
mation/Guidances/ucm1 22886.htm
 Investigational New Drug (IND) Application [Internet]. Fda.gov.
2019 [cited 1 February 2019]. Available from:
https://www.fda.gov/drugs/developmentapprovalprocess/howdru
gsaredevelopedandapproved/approvalapplications/investigation
alnewdrugindapplication/default.htm
 Fda.gov. 2019 [cited 1 February 2019]. Available from:
https://www.fda.gov/downloads/Drugs/Guidances/UCM446695.p
df
 New Drug Application (NDA) [Internet]. Fda.gov. 2019 [cited 1
February 2019]. Available from:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowD
rugsareDevelopedandApproved/ApprovalApplications/NewDrug
ApplicationNDA/default.htm