April 3, 1987

NDA SUBMISSION GUIDELINES

As part of its effort to streamline the drug review process,
FDA has completed 12 guidelines for manufacturers and other drug
sponsors of
new drug and antibiotic marketing applications. The guidelines are
intended
to assist the applicants in making good use of the new regulations
designed to
improve the new drug review process.
The guidelines were prepared by FDA's Center for Drugs and
Biologics.
Their availability is reported in the Federal Register of April 3, 1987.
Although the 12 guidelines do not include the clinical guidelines
(which the
Center for Drugs and Biologics is still working on) or the adverse
reaction
guidelines, they do represent "a substantive achievement in simplifying
the
NDA format," according to Commissioner Young.
On Feb. 22, 1985, FDA revised the regulations governing approval
for
marketing of new drugs and antibiotic drugs for human use. Generally
called
the NDA, or new drug approval, rewrite, was designed to assist drug
manufacturers in preparing and submitting higher quality applications
and to
enable FDA to review applications more efficiently while, at the same
time,
preserving or improving public health protections.
All of the guidelines that are now being made available were
previously
issued in draft form. Comments on the drafts were carefully reviewed
and
considered in the development of the final guidelines.
The guidelines now available are:
1. "Guideline for the Format and Content of the Summary for New
Drug and
Antibiotic Applications" (Docket No. 85D-0247);
2. "Guideline for the Format and Content of Chemistry,
Manufacturing,
and Controls Section of an Application" (Docket No. 85F-0243);
3. "Guideline for the Format and Content of the Nonclinical/
Pharmaco-
logy/Toxicology Section of an Application" (Docket No. 85D-0244);
4. "Guideline for the Formal and Content of the Human
Pharmacokinetics
and Bioavailability Section of an Application" (Docket No. 85D-0275);
5. "Guideline for the Format and Content of the Microbiology
Section of
an Application" (Docket No. 85D-0245);
6. "Submission in Microfiche of the Archival Copy of an
Application"
(Docket No. 85D-0250);
7. "Guideline on Formatting, Assembling, and Submitting New Drug
and
Antibiotic Applications" (Docket No. 85D-0248);
8. "Guideline for Submitting Documentation for Packaging for
Human Drugs
and Biologics" (Docket No. 84D-0015);
9. "Guideline for Submitting Documentation for the Stability of
Human
Drugs and Biologics" (Docket No. 84D-0115);
10. "Guideline for Submitting Samples and Analytic Data for Methods
Validation" (Docket No. 84D-0134);
11. "Guideline for Submitting Supporting Documentation in Drug
Applications for the Manufacture of Drug Substances" (Docket No. 85D-
0108);
12. "Guideline for Submitting Documentation for the Manufacture of
and
Controls for Drug Products" (Docket No. 85D-0078).
Requests for copies of the guidelines should be made in writing to:
Support Services Branch (HFN-62), Center for Drugs and Biologics, Food
and
Drug Administration, Rm. 13B-05, 5600 Fishers Lane, Rockville, Md.,
20857, and
should identify the desired guidelines by docket number. For further
information contact Steven H. Unger, Center for Drugs and Biologics,
Food and
Drug Administration, 5600 Fishers Lane, Rockville, Md., 20857, 301-295-
8049.