FDA has completed 12 guidelines for new drug and antibiotic marketing applications. The guidelines were prepared by FDA's Center for Drugs and Biologics. FDA revised the regulations governing approval for marketing of new drugs and antibiotic drugs.
FDA has completed 12 guidelines for new drug and antibiotic marketing applications. The guidelines were prepared by FDA's Center for Drugs and Biologics. FDA revised the regulations governing approval for marketing of new drugs and antibiotic drugs.
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FDA has completed 12 guidelines for new drug and antibiotic marketing applications. The guidelines were prepared by FDA's Center for Drugs and Biologics. FDA revised the regulations governing approval for marketing of new drugs and antibiotic drugs.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOC, PDF, TXT or read online from Scribd
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.