Overview

Abbreviated New Drug Application (ANDA) publishing and submission must be made in accordance with the standard Regulatory procedures and formats as recommended by the USFDA.

Product Development Strategy for Generic Drug - Overview

In the realm of Product Development Strategy, drug development emerges as a time-consuming, costly, and complex process linked to a high degree of uncertainty regarding the market success or failure of the drug. As such, a clear and optimized Regulatory strategy is imperative.

Overview

After the submission of the Abbreviated New Drug Application (ANDA), the USFDA may raise queries (Screening Deficiency/IRs/DRLs/CRL) to the ANDA holder for additional information/clarification on the content that has been included in the ANDA.

Response to the US FDA deficiency letters should be submitted on time with sufficient data and suitable scientific justifications to receive the approval on goal date for the ANDA.

Overview

Thorough Regulatory assessment/gap analysis of the source documents/data and the first time right quality authoring of CTD sections for an ANDA application are very vital to clear the RTR screening and also receive the approval in the first review cycle on goal date, which allows the manufacturer/ANDA holder to market the generic drug in the USA region without delay.

ANDA Post-approval Changes - Overview

ANDA post-approval changes are important throughout the lifecycle of a generic drug product. After the approval of a generic drug application and during the commercialization of the drug product, manufacturers may propose certain changes to an ANDA/DMF to optimize the operational cost, increase productivity, or due to administrative reasons.

US FDA Health Authority Interactions - Overview

Drug product manufacturers/ANDA holders should utilize the provisions in the US FDA for Health Authority interactions to harmonize developmental study expectations and bioequivalence study requirements and ensure the adequacy of the information to be included in the ANDA application.

Pre-ANDA Submissions - Overview

Pre-ANDA submission is a formal written request for feedback from the US FDA to assist applicants with generics application preparation.

ANDA Pre-Submission Facility Correspondence - Overview

As part of FDARA and GDUFA ll, the US FDA has provided generic drug manufacturers with a dedicated pathway for the development of priority generics to ensure the generic drug product reaches the market promptly. It requires ANDA Pre-submission Facility Correspondence (PFC) for expedited development and review of a priority ANDA.

Overview

Changes with the potential to impact the content of the CTD require a thorough assessment to determine the appropriate course of action. The change control impact assessment of ANDA/DMF must include a full understanding of the change, visibility of all impacted products (i.e., finished products and APIs) and must determine all countries where those products are registered.  This might also include countries where a new product submission or approval is pendin

Abbreviated New Drug Application - Overview

The Abbreviated New Drug Application (ANDA) is an application submitted to the United States Food and Drug Administration (US FDA) for the review and approval of a generic drug demonstrating bioequivalence against an already-approved innovator drug so that the generic drug can be used as a safe, effective, and low-cost alternative to the brand-name drugs.