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Review time frame: The FDA will review and issue an approval, approvable, or

non-approvable letter within 180 days of receipt of application. This period is known

as review-clock. In this period the application is reviewed by the FDA thoroughly.

During this period applicant may withdraw the application and resubmit it later.

Filing time frame: After 60 days of receiving the application, the FDA will decide

whether the application may be filed or not. If the FDA filed the application, then

applicants will be notified, otherwise the applicant will be allowed to discuss the reason

for non-filing of application with FDA (Fig. 9.5).

Guidance documents to help prepare NDAs (Source: FDA)

i. Bioavailability and bioequivalence studies submitted in NDAs or INDs and

general considerations

ii. Changes to an approved NDA or ANDA

Fig. 9.4: General requirements for filing an NDA

Fig. 9.5: Classifications of drugs in NDA

134 Industrial Pharmacy II

iii. Changes to an approved NDA or ANDA: Questions and Answers

iv. Container closure systems for packaging human drugs and biologics

v. Format and content of the microbiology section of an application

vi. Format and content of the clinical and statistical sections of an application

vii. Summary for new drug and antibiotic applications—format and content of the

summary for new drug and antibiotic applications

viii. Formatting, assembling and submitting new drug and antibiotic applications

ix. Guideline for submitting supporting documentation in drug applications for the

manufacture of drug products

x. NDAs: Impurities in drug substances

xi. Format and content of the human pharmacokinetics and bioavailability section

of an application

xii. Format and content of the nonclinical pharmacology/toxicology section of an

application

xiii. Providing clinical evidence of effectiveness for human drug and biological

products

xiv. Drug master files: Guidelines

xv. FDA IND, NDA, ANDA, or drug master file binders

xvi. PET drug applications—content and format for NDAs and ANDAs—2011

NDA forms and electronic submissions (Source: FDA)

i. Form FDA-356h. Application to market a new drug, biologic, or an antibiotic

drug for human use

ii. Form FDA-3397. User fee cover sheet

iii. Form FDA-3331. New drug application field report

iv. Guidance documents for electronic submissions

9.4 CLINICAL RESEARCH / BE (BIOEQUIVALENCE) STUDIES

BE stands for bioequivalence. It is a relative term. It denotes that a drug substance in

two or more identical dosage forms reaches the systemic circulation at the same relative

rate and to the same relative extent (Figs 9.6 and 9.7).

Fig. 9.6: Concentration–time graph of bioequivalence study of two drugs (innovator drug and sample

drug)