Clinical Submission Approval Under FDA Section 505 (b) (1)


Clinical submission filed under FDA Section 505 (b) (1) NDA is required to demonstrate a clinically significant benefit for treatment needs and statistically significant safety and efficacy objectives and endpoints. In addition, clinical Proposals under FDA Section 505 (b) (1) are new chemical entities with new indications. The new investigational drug will be administered to the patient in a new form, a new dosage form, new dose strength and patents. The pharmaceutical and / or manufacturer seeks market exclusivity for the NDA. Approval NDA under 505 (b) (1), is provided by the FDA only after an extensive phase 1, 2, 3 clinical development program. When all 3 clinical phases are complete, the pharmaceutical and / or the manufacturer submits an NDA including all the results of all studies, pre-clinical, preclinical, CMC, clinical, bioanalytical, pharmacological and pharmacokinetic FDA. NDA is filed, reviewed applications for completeness and then sent to the appropriate department of the FDA for review. Regulatory “clock” starts the list.

An NDA is the result of 10-15 years of discovery, R & D, clinical development and by the time the NDA is approved by the FDA, pharmaceutical and / or producer, has invested many years and many millions of approval. Following marketing approval, the next step and requires a 12-36 month commitment to monitor and assess new medicinal properties such as the risks, benefits, safety, efficiency, SAE reports and other. At the time of approval of the NDA, the FDA provides era and exclusive right to the submitter for the recently approved drug. The approved drugs and patent (s) are protected for up to 20 years from the date of first filing a patent application.

Under the Hatch-Waxman Act, new drug application and clinical submission process will fall into one of two categories after installation drug and background. Two categories are NDAs and andas (abbreviated) New Drug Applications. As FDA Section 505 (b), a new drug application and clinical submission is divided into sections 505 (b) (1) and 505 (b) (2). An ANDA is further defined in terms of Bioequivalence requirements and is expressed as 505 (j) application and clinical submission. The 505 (J) drug moiety is not a new material. Pharmaceutical and / or producers of filing under Section 505 (j) must adhere to the “general” approval process for drugs and clinical application submission.

NDAs and andas have QC and QA to ensure file portability, quality materials, accurate, consistent data and documents, and successful clinical and regulatory approvability outcome of FDA and other. NDAs and andas are placed in the CTD (Common Technical Document) format and format. CTD content, completeness and format will be quality controlled and quality-assured to ensure regulatory compliance and critic Dossier friendly navigation.


Leave a Reply

Your email address will not be published. Required fields are marked *