New drugs review

For many years, chemical manufacturers (makers) and pharmaceutical firms (users) as well as FDA reviewers informally used these FDA food clearance mechanisms to give new drug reviewers (e.g., toxicologists and pharmacologists) a level of comfort about the safety of an excipient contained in a finished pharmaceutical product. 

MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to acquire a better understanding of office policies, definitions, staff responsibilities, and procedures. 

In order for a sponsor to have a new drug reviewed by the Agency, the format of the Agency must be followed. There are four types of reviews that take place. 

NDAs are forwarded to one of CDER s 14 new drug review divisions—specifically, the division that handles the therapeutic area relevant to the submission. Within 45 days of the NDA s submission, FDA reviewers—including the lead medical, chemistry, and pharmacology reviewers— will meet to determine if the application is sufficiently complete for a full review. NDAs that meet minimum submission criteria are filed, or accepted for review, while the FDA issues refuse-to-file (RTF) decisions for deficient applications, which are returned to their sponsors. Once the review team decides that an NDA is fileable, it begins the primary review of the application. During this evaluation, each member of the review team sifts through volumes of research data and information applicable to his or her expertise ... 

Since 1977, the FDA has undertaken a number of initiatives to simplify and clarify the new drug review process and to expedite the review of new drugs identified by the agency as therapeutically important. Most of the initiatives were implemented in the late 1980s, so their effects, if any, on the cost or speed of the R D process may not yet be discernible. 

Figure 2. The Investigational New Drug review process chart describing the reviews and decision points leading to an acceptable IND application.

Responsibility for the review and assessment of pre-marketing submissions for new drugs and devices is divided between four specialist centres. 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

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