FDA Applications for Drugs and Biologics

The process of bringing new drugs and biological products to the market is a complex and rigorous one, especially since it is aimed at ensuring the safety and efficacy of these products for public use.

The United States Food and Drug Administration (US FDA) plays a vital role in regulating these products and approving their marketing.

To get the drug approval and clearance, pharmaceutical and biotech companies must submit various applications to the FDA. Some of these applications are very common ones, while others may be very unique.

Today, we are going to take you through 5 of these most common applications one by one.

Application #1

Investigational New Drug (IND) Application

The IND serves as a formal request to the FDA seeking approval to commence clinical testing in human subjects.

The IND application contains data supporting the proposed clinical trials, ensuring they are conducted ethically and are scientifically sound to assess the drug’s safety and efficacy in humans.

Who needs it & When?

It applies to any individual or a company that is planning to conduct clinical trials with a new drug or with an already approved drug with a new indication in the US. This includes:

  • Pharmaceutical Companies
  • Academic and Research Institutions
  • Individual Investigators

What to submit?

(IND) Application

The IND includes the following components:

  • Chemistry, Manufacturing, and Controls (CMC) Information:

This section includes information about the drug’s composition, manufacturing processes, quality control procedures, and stability data. It guarantees the drug’s consistent manufacturing while maintaining the desired quality.

  • Pharmacology and Toxicology Data

This section provides preclinical data from laboratory tests and animal studies that demonstrate the drug’s pharmacological activity, potential mechanisms of action, and information regarding its safety profile.

  • Clinical Protocols and Investigator Details
  • Clinical investigation plans aimed at evaluating early-stage trial hazards to participants, covering study structure, patient group, dosage schedules, and assessment techniques.
  • Qualifications of clinical investigators, usually physicians, oversee the drug administration to ensure they can fulfill their trial responsibilities
  • Commitments to secure informed consent from research subjects have the study reviewed by an institutional review board (IRB)
  • If applicable, data from prior human studies, such as early-phase clinical trials or studies conducted in other countries.

What is the timeframe that FDA takes to review the IND application?

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The FDA takes 30 calendar days to review the application.

What to expect after the FDA review?

An IND application may become effective in two scenarios:

30-Day Default

The application takes effect after 30 days from FDA receipt unless the FDA informs the sponsor that the investigations outlined are under a Clinical Hold.

Early Notification

The application becomes effective if the FDA notifies the sponsor before the 30-day period elapses, indicating that the clinical investigations described can commence.

Compared to the year 2021, there has been a notable increase in the volume of IND applications during the year 2022. (Source)

Year Commercial IND Research IND

Application #2 New Drug Application (NDA)

After the conclusion of clinical trials and the collection of data regarding the safety and effectiveness of a drug, pharmaceutical companies initiate the next step by submitting NDA to the FDA.

This submission is part of the process to obtain FDA approval for the marketing and distribution of a new drug within the US.

What to submit?

What to submit in New Drug Application (NDA)

The essential elements of an NDA encompass not only CMC information but also a range of other crucial components:

  • Preclinical Data

Information from laboratory studies and animal testing to establish the product’s safety profile, potential toxicity, and initial efficacy. This data helps predict the product’s potential effects on humans.

  • Clinical Data

The most critical component, involves information from human trials conducted in different phases to evaluate safety and efficacy. This section presents data on patient populations, study design, endpoints, statistical analyses, and adverse events.

  • Labeling and Proposed Usage

This section outlines how the company intends to market and label the product. It includes information about dosing, route of administration, indications, contraindications, warnings, precautions, potential side effects, advertising, and promotional materials.

  • Risk-Benefit Analysis

Pharmaceutical manufacturers must demonstrate that the potential benefits of the product outweigh its risks. This involves presenting a thorough analysis of both the clinical benefits and potential adverse effects.

What is the timeline FDA takes to review?

Upon receiving an NDA, the FDA initiates a review process.

What to expect after the FDA review?

After the FDA completes its review, the following outcomes are possible, each contingent on the evaluation of the submitted data, safety, efficacy, and overall quality of the drug. Here’s what can be expected:

  • The review team assesses whether the NDA is complete or not
  • If the NDA is incomplete, the FDA will issue a refusal-to-file notice
  • If the NDA is complete, the review team has a window of 6 to 10 months for decision-making


If the FDA is satisfied with the submitted data, they grant approval. The FDA may also specify conditions, such as post-marketing studies or additional safety monitoring.

Complete Response Letter

If the FDA needs more information to make a decision, they send a Complete Response Letter (CRL) that lists what data is missing and what additional information is needed.

As of early August 2023, the FDA has approved 32 novel drugs via NDA.

It’s crucial to acknowledge that the FDA’s assessment is a thorough procedure aimed at guaranteeing that drugs brought to the market adhere to required benchmarks in terms of safety, effectiveness, and quality.

Feel free to get in touch with us if you require assistance with any of your upcoming applications. We’re here to assist you throughout the draft and review process, ensuring a seamless path toward approval. Don’t hesitate to reach out for expert guidance tailored to your needs.

Application #3 - Biologics License Application (BLA)

A BLA is similar to an NDA but is specifically used for biological products, which are products derived from living organisms or their components.

Biological products include vaccines, blood products, gene therapies, monoclonal antibodies, and other biotechnologically-produced therapies.

What to submit?

The key components of a BLA are similar to those in an NDA, including preclinical and clinical data, manufacturing information, proposed labeling, and marketing materials.

What is the timeline does FDA take to review?

The timeline for FDA review of a BLA generally aims to be completed within 10 months from the date of submission, with the Prescription Drug User Fee Act (PDUFA) goal date serving as a target. However, actual timelines can vary based on factors such as application complexity and the need for additional information or assessments.

What to expect after the FDA review?

In this context, the results of the submission evaluation mirror those of the NDA process. The FDA’s decision encompasses either granting approval for market distribution or issuing a letter that outlines identified deficiencies.

Application #4 - Abbreviated New Drug Application (ANDA)

An ANDA is a submission made for generic drugs that are intended to be identical to a previously approved reference (brand-name) drug.

To secure FDA approval via an ANDA, the demonstration of bioequivalence is essential to ensure that the generic drug functions in the same manner as the reference drug and produces similar therapeutic effects in patients.

What to submit?

The ANDA does not require extensive clinical trials as the generic drug’s safety and efficacy are already demonstrated by the reference drug‘s data. Instead, the generic manufacturer must show that its product is pharmaceutically equivalent (i.e., contains the same active ingredient in the same dosage form and strength) and is bioequivalent (i.e., behaves in the body similarly to the reference drug). Further, the following must be included:

  • Patent Certification

Statements of patent certification, indicating whether the generic drug infringes on any existing patents for the brand-name reference product

  • Bioequivalence Studies

Data from bioequivalence studies that compare the generic drug’s performance in the body to that of the brand-name reference product. This is a critical element to show that the generic drug performs similarly to the reference product

  • Environmental Impact Assessment (if applicable)

Information regarding the potential environmental impact of the drug’s manufacturing and disposal processes

Also, like other submissions, the manufacturer shall submit CMC data and proposed labeling.

What is the timeline does FDA take to review?

The FDA takes 10 months for standard ANDA and 8 months for priority ANDA.

What to expect after the FDA review?

Here, the outcomes of the submission review are the same as those of the NDA application. The FDA either provides approval for marketing or will share a deficiency letter.

ANDA or 505(b)(2) Choosing the Right Abbreviated Approval Pathway for Your Drug
You can also check out our blog on ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug to understand more about both ANDA or 505(b)(2).

Application #5 - OTC Monograph

The purpose of OTC Monographs is to facilitate the availability of safe and effective nonprescription medications to the public without the need for individual pre-approval for each product.

Monographs cover a wide array of therapeutic categories, such as pain relievers, cough and cold medications, antacids, sunscreens, and more.

The Monograph specifies:

It’s important to note that the manufacturer assigns someone to look at the FDA database, as OTC Monographs are continually updated and refined to incorporate new scientific findings and advancements in medical knowledge, ensuring that nonprescription drugs remain safe and beneficial for public use. Looking for a long-term partnership for this, call us now.

  • Acceptable ingredients and their concentrations
  • Usage indications
  • Dosage recommendations
  • Safety information
  • Labeling requirements


Navigating the FDA’s regulatory pathway for drugs, and biological products, requires careful planning, rigorous data collection, and adherence to strict guidelines.

The different applications symbolize essential stages within the process, enabling businesses to showcase the safety and effectiveness of the products prior to their introduction to the market.

By understanding the purposes and requirements of these applications, pharmaceutical and biotech companies can ensure innovative and safe healthcare solutions reach the public.

A skilled consultant can greatly assist your Drug and Biologics application process to the FDA by providing expert guidance on regulatory requirements, streamlining documentation, and ensuring adherence to rigorous standards.

From crafting comprehensive submission strategies to conducting thorough reviews of application materials, Elexes’ insights can enhance the quality and accuracy of submissions, increasing the likelihood of successful approvals. For personalized assistance with your specific application needs, please feel free to email us now, and we can set up a call to discuss.

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.