SMG 1264.43

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF NEW DRUG QUALITY ASSESSMENT

DIVISION OF NEW DRUG QUALITY ASSESSMENT III

Effective Date: 01/12/2010

1. DIVISION OF NEW DRUG QUALITY ASSESSMENT III (DBNSCC). 

A. Assesses the pharmaceutical quality of new drug IND and NDA submissions by conducting critical quality reviews and identifying, communicating, and resolving approvability issues for IND and NDA assigned to the Division.

B. Assesses the critical quality attributes and their relevance to safety and efficacy, which encompasses chemistry, formulations, manufacturing processes, dosage forms, product performance, etc.

C. Evaluates and formulates decisions or recommendations regarding approvability in accordance with applicable delegation of authority on the suitability of manufacturing methods and controls, drug product designs, and related facilities proposed by IND sponsors and NDA applicants.

D. Evaluates and assesses chemistry, manufacturing, and controls (CMC) specifications based on: risk-based assessments; clinical relevance (performance and safety considerations); process knowledge and understanding; and utilization of modern statistical methodologies.

E. Streamlines the supplement review process and develops meaningful strategies to reduce and eliminate the need for certain types of supplements.

F. Performs the initial screening, or triaging, of supplements by pharmaceutical scientist, who then determines if/what type of ONDQA resources are needed to complete the quality review of supplements.

G. Evaluates supplements and formulates decisions on whether the supplements are eligible for immediate approval or require further review by pharmaceutical scientist.

H. Evaluates whether a supplement necessitates critical manufacturing changes that require comprehensive review from the ONDQA.

I. Assesses annual reports and evaluates the post-marketing reporting system.

J. Provides engineering and scientific expertise with an understanding of manufacturing processes and controls, as well as updated knowledge and skills in pharmaceutical dosage forms, process analytical techniques, and industrial pharmacy.

K. Supplies scientific input to address critical pharmaceutical manufacturing issues for pre- and post-approval.

L. Addresses and identifies critical manufacturing issues for inspection/enforcement and consults with the Office of Compliance.

M. Establishes a criteria and standards to be used by Reviewers in pre- and post-marketing divisions.

2. BRANCH VII (DBNSCC1). 

A. Assesses the pharmaceutical quality of new drug IND and NDA submissions for Medical Imaging, Over-the-Counter, and Endocrinology products; conducts critical quality reviews and identifies, communicates, and resolves approvability issues

B. Assesses the critical quality attributes and their relevance to safety and efficacy, which encompasses chemistry, formulations, manufacturing processes, dosage forms, product performance, etc.

C. Evaluates and formulates decisions or recommendations regarding approvability in accordance with applicable delegation of authority on the suitability of manufacturing methods and controls, drug product designs, and related facilities proposed by IND sponsors and NDA applicants.

D. Evaluates and assesses chemistry, manufacturing, and controls (CMC) specifications based on: risk-based assessments; clinical relevance (performance and safety considerations); process knowledge and understanding; and utilization of modern statistical methodologies.

E. Provides engineering and scientific expertise with an understanding of manufacturing processes and controls, as well as updated knowledge and skills in pharmaceutical dosage forms, process analytical techniques, and industrial pharmacy.

F. Supplies scientific input to address critical pharmaceutical manufacturing issues for pre-approval.

G. Addresses and identifies critical manufacturing issues for inspection/enforcement and consults with the Office of Compliance.

3. BRANCH VIII (DBNSCC2). 

A. Assesses the pharmaceutical quality of new drug IND and NDA submissions for Pulmonary, Allergy, Anesthesia, Analgesia, and Rheumatology products; conducts critical quality reviews and identifies, communicates, and resolves approvability issues.

B. Assesses the critical quality attributes and their relevance to safety and efficacy, which encompasses chemistry, formulations, manufacturing processes, dosage forms, product performance, etc.

C. Evaluates and formulates decisions or recommendations regarding approvability in accordance with applicable delegation of authority on the suitability of manufacturing methods and controls, drug product designs, and related facilities proposed by IND sponsors and NDA applicants.

D. Evaluates and assesses chemistry, manufacturing, and controls (CMC) specifications based on: risk-based assessments; clinical relevance (performance and safety considerations); process knowledge and understanding; and utilization of modern statistical methodologies.

E. Provides engineering and scientific expertise with an understanding of manufacturing processes and controls, as well as updated knowledge and skills in pharmaceutical dosage forms, process analytical techniques, and industrial pharmacy.

F. Supplies scientific input to address critical pharmaceutical manufacturing issues for pre-approval.

G. Addresses and identifies critical manufacturing issues for inspection/enforcement and consults with the Office of Compliance.

4. BRANCH IX (DBNSCC3). 

A. Assesses the pharmaceutical quality of supplemental new drug SNDA submissions for Medical Imaging, Over-the-Counter, Endocrinology, Pulmonary, Allergy, Anesthesia, Analgesia, and Rheumatology products; conducts critical quality reviews and identifies, communicates, and resolves approvability issues.

B. Assesses the critical quality attributes and their relevance to safety and efficacy, which encompasses chemistry, formulations, manufacturing processes, dosage forms, product performance, etc.

C. Evaluates and formulates decisions or recommendations regarding approvability in accordance with applicable delegation of authority on the suitability of manufacturing methods and controls, drug product designs, and related facilities.

D. Evaluates and assesses chemistry, manufacturing, and controls (CMC) specifications based on: risk-based assessments; clinical relevance (performance and safety considerations); process knowledge and understanding; and utilization of modern statistical methodologies.

E. Evaluates supplements and formulates decisions on whether the supplements are eligible for immediate approval or require further review by pharmaceutical scientist.

F. Evaluates whether a supplement necessitates critical manufacturing changes that require comprehensive review from the ONDQA.

G. Assesses annual reports and evaluates the post-marketing reporting system.

H. Provides engineering and scientific expertise with an understanding of manufacturing processes and controls, as well as updated knowledge and skills in pharmaceutical dosage forms, process analytical techniques, and industrial pharmacy.

I. Supplies scientific input to address critical pharmaceutical manufacturing issues for post-approval.

J. Addresses and identifies critical manufacturing issues for inspection/enforcement and consults with the Office of Compliance.

5. AUTHORITY AND EFFECTIVE DATE. 

This functional statement was approved by the Commissioner of Food and Drugs on January 12, 2010.