As part of its effort to streamline the drug review process,
FDA has completed 12 guidelines for manufacturers and other drug
new drug and antibiotic marketing applications. The guidelines are
to assist the applicants in making good use of the new regulations
improve the new drug review process.
The guidelines were prepared by FDA's Center for Drugs and
Their availability is reported in the Federal Register of April 3, 1987.
Although the 12 guidelines do not include the clinical guidelines
Center for Drugs and Biologics is still working on) or the adverse
guidelines, they do represent "a substantive achievement in simplifying
NDA format," according to Commissioner Young.
On Feb. 22, 1985, FDA revised the regulations governing approval
marketing of new drugs and antibiotic drugs for human use. Generally
the NDA, or new drug approval, rewrite, was designed to assist drug
manufacturers in preparing and submitting higher quality applications
enable FDA to review applications more efficiently while, at the same
preserving or improving public health protections.
All of the guidelines that are now being made available were
issued in draft form. Comments on the drafts were carefully reviewed
considered in the development of the final guidelines.
1. "Guideline for the Format and Content of the Summary for New
Antibiotic Applications" (Docket No. 85D-0247);
2. "Guideline for the Format and Content of Chemistry,
and Controls Section of an Application" (Docket No. 85F-0243);
3. "Guideline for the Format and Content of the Nonclinical/
logy/Toxicology Section of an Application" (Docket No. 85D-0244);
4. "Guideline for the Formal and Content of the Human
and Bioavailability Section of an Application" (Docket No. 85D-0275);
5. "Guideline for the Format and Content of the Microbiology
an Application" (Docket No. 85D-0245);
6. "Submission in Microfiche of the Archival Copy of an
(Docket No. 85D-0250);
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