Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Look up keyword
Like this
3Activity
0 of .
Results for:
No results containing your search query
P. 1
NDa Submission

NDa Submission

Ratings: (0)|Views: 272|Likes:
Published by api-3810976

More info:

Published by: api-3810976 on Oct 18, 2008
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as DOC, PDF, TXT or read online from Scribd
See more
See less

03/18/2014

pdf

text

original

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

Activity (3)

You've already reviewed this. Edit your review.
1 thousand reads
1 hundred reads
nlakshminarayana liked this

You're Reading a Free Preview

Download
scribd
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->