| A clinical submission filed under FDA Section 505(b)(1) | | | | the time of approval of an NDA, FDA grants a period |
| is an NDA is required to demonstrate clinically | | | | and right of exclusivity to the submitter for the |
| meaningful treatment benefits and statistically | | | | newly approved drug. The approved drug and |
| significant safety and efficacy objectives and | | | | patent(s) are protected for up to 20 years from the |
| endpoints. In addition, clinical submissions filed under | | | | date of the first filing of the patent application. |
| FDA Section 505(b)(1) are a new chemical entities | | | | Under the Hatch-Waxman Act, a new drug |
| with a new indications. The new investigational drug | | | | application and clinical submission process will fall into |
| will be administered to the patient in a new | | | | one of two categories depending on drug profile and |
| formulation, with a new dosage form, new dose | | | | background. The two categories are NDAs and |
| strength and is patented. The pharmaceutical | | | | ANDAs (Abbreviated) New Drug Applications. Under |
| company and/or manufacturer seeks market | | | | FDA Section 505(b), a new drug application and clinical |
| exclusivity for the NDA. Approval of the NDA under | | | | submission is further divided into Sections 505(b)(1) |
| Section 505(b)(1), is granted by FDA only after an | | | | and 505(b)(2). An ANDA is further delineated with |
| extensive Phase 1, 2, 3 clinical development program. | | | | respect to Bioequivalence requirements and is |
| When all 3 clinical phases are complete, the | | | | submitted as a 505(j) application and clinical |
| pharmaceutical company and/or manufacturer, | | | | submission. The 505(j) drug moiety is not a new |
| submits an NDA including all results from all studies, | | | | chemical. Pharmaceutical companies and/or |
| nonclinical, preclinical, CMC, clinical, bioanalytical, | | | | manufacturers filing under Section 505(j) must follow |
| pharmacologic and pharmacokinetic to FDA. The NDA | | | | the "generic" approval process for drug application |
| is filed, reviewed for filing completeness and then | | | | and clinical submission. |
| sent to the appropriate division at FDA for review. | | | | NDAs and ANDAs require QC and QA to ensure |
| The regulatory "clock" begins for the file. | | | | fileability, quality content, accurate, consistent data |
| An NDA is the culmination of 10-15 years of | | | | and documentation and a successful clinical and |
| discovery, R&D, clinical development and by the time | | | | regulatory approvability outcome with FDA and |
| an NDA is approved by FDA, the pharmaceutical | | | | otherwise. NDAs and ANDAs are submitted in a CTD |
| company and/or manufacturer, has invested | | | | (Common Technical Document) presentation and |
| numerous years and many millions for the approval. | | | | format. CTD content, completeness and format must |
| Post-marketing, post-approval is the next step and | | | | be quality-controlled and quality-assured to ensure |
| requires a 12 - 36 month commitment to monitor and | | | | regulatory compliance and reviewer friendly dossier |
| assess new drug attributes such as risk, benefit, | | | | navigation. |
| safety, effectiveness, SAE reports and otherwise. At | | | | |