An Abbreviated New Drug Application (ANDA) is a submission to the FDA for the approval of generic drugs, demonstrating that the proposed drug is equivalent in safety, efficacy, and quality to a previously approved reference-listed drug (RLD).
The ANDA includes information on the drug’s active ingredients, usage, administration, form, potency, labeling, and bioavailability to prove its bioequivalence to the RLD.
While an ANDA can include minor differences from the RLD, like inactive ingredients or packaging, it cannot be submitted if clinical trials are needed to confirm the drug’s safety and efficacy. In such cases, additional testing and evaluation are mandatory.
The ANDA process, established by the Hatch-Waxman Act of 1984, facilitates the approval of generic drugs by amending the Federal Food, Drug, and Cosmetic Act.
The act was designed to boost competition and lower prescription drug costs by allowing generic drug makers to bypass some costly clinical trials if their product is deemed equivalent to an approved drug.
This has led to an influx of affordable generic drugs, enhancing accessibility for millions and embodying Congress's intent to balance increased generic access with incentives for new drug development via exclusivities and patent extensions. Consequently, the FD&C Act now specifies two separate pathways for drug approval: NDAs for new drugs and ANDAs for generic equivalents.
ANDAs can be divided into two categories:
This is approved under section 505(j) of the FD&C Act for a drug that is identical to a previously approved drug. It relies on the FDA’s prior approval of the RLD, affirming its safety and effectiveness.
This applies to a drug that varies in dosage form, administration route, strength, or active ingredient from the RLD. Approval is granted when the FDA, responding to a petition under section 505(j)(2)(C) of the FD&C Act, confirms that no additional studies are needed to verify the proposed drug's safety and effectiveness. The drug is expected to offer the same therapeutic benefits as the RLD.
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As a brief aside, NDAs can also be classified into two types: Stand-alone NDAs and 505(b)(2) Applications.
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Here is a surface-level overview of the steps involved in submitting an ANDA for FDA approval.
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Experienced regulatory consultants are pivotal in streamlining and enhancing the submission process for generic drug approval. Here’s how they can be instrumental at various stages.
During the preparation phase, consultants offer insights into the intricate details of the RLD, ensuring a comprehensive understanding of its properties and regulatory history. They also assist in gathering and analyzing relevant data, ensuring that the generic drug aligns with the RLD’s safety and efficacy standards.
Also, by identifying potential challenges early, consultants help devise strategies to mitigate risks and enhance approval chances.
When developing the ANDA, consultants aid in preparing robust documentation, ensuring that all regulatory, clinical, and quality requirements are meticulously addressed. They ensure that the submission adheres to FDA guidelines, reducing the likelihood of queries or rejections. With their expertise, consultants expedite the preparation process, ensuring timely and accurate submission.
During submission, consultants are adept at navigating the FDA’s electronic submissions gateway, ensuring that the ANDA is submitted accurately and securely. They can also maintain communication with the FDA, addressing questions and providing additional information as required, ensuring a smooth review process.
After the FDA's decision, consultants help interpret the FDA’s feedback, whether it’s an approval or rejection, and advise on the next steps. In case of rejection, they assist in developing a responsive strategy to address the FDA’s concerns, enhancing the prospects of future approval.
Deciding whether to submit an ANDA or a 505(b)(2) application is a crucial decision for companies aiming to bring a new drug or a generic version of an existing drug to the market.
Generally speaking, companies pursue ANDAs when they're aiming to introduce a generic, bioequivalent version of an existing, approved drug. They choose the 505(b)2) pathway if the drug has modifications and requires additional data to support its safety and efficacy while leveraging existing approved drug data.
Here are the steps and considerations that companies should take into account:
If you're considering submitting an ANDA, numerous resources are available to assist with your application and submission process. These resources are designed to guarantee that your ANDA submissions are thorough, precise, and compliant with all regulatory standards.
The ANDA submission process can be extensive and requires meticulous attention to detail. Failing to align your product with the submission guidelines can potentially derail your project and lead to costly mistakes.
At The FDA Group, we provide comprehensive regulatory consulting assistance for ANDA compilation and submission. We've helped hundreds of companies identify and overcome the many obstacles encountered during the ANDA process and ensure a smooth approval process for their products. Contact us when you're ready to move your produce to market and keep it there.
Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.
Our experts prepare all major regulatory submissions and provide extensive quality control review for all trial-related documentation, such as:
Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:
Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.
Here's a look at a typical ANDA scope of services, to give you a better idea of how our ANDA consulting engagements play out. Head to our ANDA service page for more.
Contact us to learn more about our ANDA support services.