Pre-Approval Process INAD vs. NADA

Transcription

1 Pre-Approval Process INAD vs. NADA Barbara M. Leotta, DVM CVM/ONADE/DTDNFA (240) Pre-Approval Process General Overview Pathways To Legal Marketing Office of New Animal Drug Evaluation (ONADE) Technical Sections Pathways to Legal Marketing Approved New Animal Drug Application (NADA) Traditional Administrative Approved Abbreviated New Animal Drug Application (ANADA) Conditional Approval Index Listing

2 Office of New Animal Drug Evaluation The Office of New Animal Drug Evaluation's (ONADE) major responsibility is to review information submitted by drug sponsors who want to obtain approval to manufacture and market new animal drugs. NADA Background Information What does an approved NADA mean? The product is safe and effective for its intended use The methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity Traditional NADA A complete NADA is composed of the requirements identified in 21 CFR Required information for evaluation of the NADA is grouped into technical sections Technical sections are reviewed concurrently One review clock for entire NADA Outcomes Approval Letter or Incomplete Letter

3 Administrative NADA Submitted after all of the required technical sections have been reviewed by CVM and CVM has issued a technical section complete letter for each of those technical sections under the INAD, phased review process. A final decision on the approval of an application will be made when the Administrative NADA is submitted and CVM evaluates whether all the data for all technical sections viewed as a whole support approval. INAD Phased Review A sponsor may submit data or information in support of a technical section, or a complete technical section, of the NADA for review during the investigation of the new animal drug, i.e., for phased review. INAD Phased Review The same requirements under 21 CFR apply to all NADAs whether for phased review or not. Phasing of technical section submissions is voluntary. The option to phase the review of data submissions applies to all original NADAs and to supplemental NADAs, up to the point at which the sponsor submits an NADA or supplemental NADA.

4 INAD Phased Review Allows sponsors to submit data for review at the most appropriate and productive times in the drug development process rather than submitting all data at one time. INAD Phased Review Provides for protocol review to increase likelihood data will support approval. Submissions containing technical information should be submitted to the investigational new animal drug (INAD) file for direct review by the Division responsible for the technical evaluation. INAD Phased Review The reviewing Division will notify the sponsor in writing of its conclusions on acceptance or non- acceptance of the data submitted relevant to a technical section. If the reviewing Division finds the data for the technical section to be complete, it will issue a technical section complete letter. When CVM finds that all the required sections are complete, the sponsor may file the administrative NADA.

5 Technical Sections Technical requirements of an NADA as defined in Each technical section must support a condition of approval required by CVM. All studies supporting a single technical section should be submitted as well as all other relevant information such as referenced literature, foreign market experience, etc. A technical section should also contain information on the proposed conditions of use and/or labeling, and the relevant portion(s) of the FOI Summary. Technical Sections Major Technical Sections Target Animal Safety Effectiveness Human Food Safety Chemistry, Manufacturing, and Controls Environmental Impact Technical Sections Minor Technical Sections All Other Information Labeling Freedom of Information Summary

6 TAS The Target Animal Safety section must contain full reports of adequate tests by all methods reasonably applicable to show whether or not the new animal drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling. Effectiveness The Effectiveness section must contain full reports of all adequate tests by all methods reasonably applicable to show whether or not the new animal drug is effective as suggested in the proposed labeling. An application may be refused unless it contains substantial evidence consisting of one or more adequate and well-controlled investigations, such as-- Effectiveness A study in a target species A study in laboratory animals Any field investigation A bioequivalence study An in vitro study

7 HFS The Human Food Safety section is submitted only for species that are used for human food. Human Food Safety TOXICOLOGY: determine the no observable effects level (NOEL), acceptable daily intake (ADI), and safe concentration RESIDUE CHEMISTRY: determine the target tissue, marker residue, slaughter withdrawal, and milk withhold times MICROBIAL FOOD SAFETY: evaluate the safety of antimicrobials with regard to their microbiological effects on bacteria of human health concern (Guidance 152 and 159) REGULATORY METHOD: development and validation of methods to measure drug residues in edible tissues CMC The Chemistry, Manufacturing, and Controls section should contain complete information regarding the manufacture of the new animal drug active ingredient and the new animal drug product. Determines whether an animal drug will have and maintain the necessary quality, strength, purity, and identity Methods and controls Stability data GMP compliance

8 Environmental The Environmental Impact section contains either an environmental assessment (EA) under 21 CFR 25.40, or a request for categorical exclusion under 21 CFR or Under 21 CFR 25.15(a), a claim of categorical exclusion must include a statement of compliance with the categorical exclusion criteria and must state that to the sponsor s s knowledge, no extraordinary circumstances exist. AOI The All Other Information section includes all other information, not included in any of the other technical sections, that is pertinent to an evaluation of the safety or effectiveness of the new animal drug for which approval is sought. All other information includes, but is not limited to, any information derived from other marketing (domestic or foreign) and favorable and unfavorable reports in the scientific literature. Labeling The Labeling section should include facsimile copies of container labels, package inserts and any other labeling that will be used with the products. Facsimile labeling is nearly final labeling that adequately reproduces the package size (actual or to scale); graphics; pictures; type size, font, and color of text; and, the substance of the text.

9 FOI Summary The Freedom of Information Summary provides the public a summary of the safety and effectiveness data on which we based our decision to approve the new animal drug. The completed FOI Summary will include the specific language relevant to a technical section that was agreed upon during the review of the individual technical section. FDA/CVM s Responsibilities Protect the Public Health by ensuring safe and effective new animal drugs reach the market unsafe and ineffective new animal drugs do not reach the market Work efficiently to process and review sponsor submissions and applications Meet or Exceed user fee performance goals Work within the limits of statutory authority Thank You!