A Comprehensive Guide to Registering a Medicinal Product in the U.S.

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Team Strategy for Registering Medicinal Product in the U.S.

Step-by-step guide to FDA drug registration with timelines, costs, and approval shortcuts

Understanding Drug Classification

Registering a medicinal product to market in the United States is a rigorous process governed by the Food and Drug Administration (FDA). Whether you are developing a new drug, a generic equivalent, a biologic, or an over-the-counter (OTC) medication, compliance with strict regulatory standards is essential. Understanding the classification of a medicinal product is the first crucial step before initiating the registration process. The FDA categorizes medicinal products into four main types: new drugs, generic drugs, biologics, and over-the-counter (OTC) drugs[1]. New drugs require full clinical trials to establish safety and efficacy, whereas generic drugs must demonstrate bioequivalence to an already approved reference drug[4]. Biologics include complex products such as vaccines and gene therapies, which require extensive safety and potency testing[5]. OTC drugs can be marketed without a New Drug Application (NDA) if they comply with an established FDA OTC monograph[6]. Identifying the correct category ensures the appropriate regulatory pathway is followed.

In this article we will take a look at the requirements in registering a medicinal product in the U.S. as well as some of the key criteria governing the registration process.

Considering the Criteria for Medicinal Product Registration in the U.S.

Before registering a medicinal product in the U.S., it is crucial to consider several key criteria that will influence the approval process. The FDA’s regulatory framework is complex and designed to ensure that products are both safe and effective for public use. These criteria include the type of product, the regulatory pathway, and the clinical data requirements. For example, a new drug will require substantial clinical evidence to support its safety and efficacy, while generic drugs rely on bioequivalence studies to demonstrate similarity to an already approved product. Biologics and over-the-counter (OTC) drugs have additional considerations, such as manufacturing processes and compliance with specific FDA monographs. Understanding the appropriate regulatory pathway—whether through a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA)—is essential in determining the right strategy for submitting a medicinal product. Navigating these requirements effectively is the first step in the registration process, setting the foundation for the subsequent stages, including preclinical development and the Investigational New Drug (IND) application.

Preclinical Development and Investigational New Drug (IND) Application

For new drugs and biologics, preclinical development is required before human testing can begin. This phase involves conducting laboratory and animal testing to assess toxicity, pharmacokinetics, and pharmacodynamics[1]. Preclinical studies provide critical safety data that must be submitted to the FDA to determine whether the medicinal product is suitable for human trials. Successful results in preclinical trials are a prerequisite for advancing to the investigational phase. Before conducting human trials, pharmaceutical companies must submit an Investigational New Drug (IND) application to the FDA[2]. This application includes preclinical study data, proposed clinical trial design, manufacturing information, and safety measures for human testing. The FDA reviews the IND application within thirty days, and if there are no objections, the clinical trials may commence. This phase is crucial for determining how the drug behaves in the human body and assessing its potential benefits and risks.

Clinical Trials: Phases of Testing

Clinical trials for new drugs and biologics occur in three phases. Phase 1 trials involve a small group of volunteers, typically between twenty and one hundred participants, to evaluate safety and dosage. Phase 2 trials expand to a larger group of one hundred to five hundred patients to assess effectiveness and identify side effects. Phase 3 trials are large-scale studies involving over one thousand participants to confirm the drug’s overall benefits, risks, and impact on a broader patient population[1]. The successful completion of all three phases is necessary before the drug can be considered for regulatory approval.

New Drug Application (NDA) and Biologics License Application (BLA)

Once clinical trials are successfully completed, the next step is submitting either a New Drug Application (NDA) for new drugs or a Biologics License Application (BLA) for biologics. These applications must include full clinical trial data, detailed manufacturing and quality control information, proposed labeling, patient information, and risk mitigation strategies[3]. The FDA rigorously reviews these applications, assessing all aspects of the drug’s safety, efficacy, and quality before granting approval for market release.

Generic Drug Approval through Abbreviated New Drug Application (ANDA)

For manufacturers of generic drugs, the approval process follows a different route through an Abbreviated New Drug Application (ANDA). Rather than requiring new clinical trials, generic drug manufacturers must demonstrate that their product is bioequivalent to an existing Reference Listed Drug (RLD)[4]. This means the generic drug must deliver the same active ingredient at the same rate and extent as the original drug. The ANDA process allows for a faster and more cost-effective pathway to market while ensuring the safety and effectiveness of the generic version.

Over-the-Counter (OTC) Drug Approval Process

Over-the-counter (OTC) drugs follow a different regulatory pathway. If an OTC drug adheres to an existing FDA OTC monograph, which outlines approved active ingredients, dosages, and labeling requirements, it can be marketed without requiring a new NDA. However, if the drug does not fit within the monograph’s specifications, an NDA must be submitted to gain FDA approval before it can be sold to consumers[6].

Compliance with Current Good Manufacturing Practices (cGMP)

All drug manufacturers must comply with Current Good Manufacturing Practices (cGMP) regulations as outlined in 21 CFR Parts 210 and 211. These regulations ensure that medicinal products are consistently produced and controlled according to quality standards[8]. The FDA conducts routine inspections of manufacturing facilities to verify compliance, and failure to meet these standards can result in regulatory action, including product recalls or legal penalties[7].

Drug Labeling and Marketing Regulations

Drug labeling and marketing are also heavily regulated by the FDA. The labeling must provide accurate dosing instructions, clearly list side effects and contraindications, and disclose all active and inactive ingredients in the product[3]. Any promotional materials, including advertisements and physician-directed information, must comply with FDA advertising regulations, which prohibit false or misleading claims about the drug’s benefits and risks[1]. Ensuring compliance with these requirements is essential to avoid regulatory enforcement actions.

Post-Market Surveillance and Adverse Event Reporting

Once a medicinal product is on the market, manufacturers must continue to monitor its safety through post-marketing surveillance. This includes conducting Phase 4 trials in some cases to gather additional data on long-term use and effectiveness. Additionally, manufacturers are required to report adverse events to the FDA Adverse Event Reporting System (FAERS)[9]. Ongoing pharmacovigilance ensures that any emerging safety concerns are promptly identified and addressed to protect public health.

FDA Submission Fees for Registering Medicinal Products in the U.S.

The FDA requires submission fees for all medicinal product applications, and these fees differ depending on the type of product being submitted. These fees are updated annually and play a crucial role in the overall cost structure of bringing a product to market. Understanding the specific submission fees for different categories—such as new drugs, biologics, generic drugs, and over-the-counter (OTC) drugs—can help pharmaceutical companies plan their finances and streamline their development timelines. The table below outlines the FDA submission fees for FY 2024 based on product category and application type. For the latest and most accurate fee information, visit the FDA User Fee Rates website[10].

Table 1: Showing the Product Category and Approximate Cost of Submission Fess to FDA. Check FDA User Fee Rates Website for more updated information.

Product CategoryApplication TypeFDA Submission Fee (FY 2024)/USDClinical Data Required?Notes
New DrugNew Drug Application (NDA)$4,048,695YesStandard PDUFA fee for NDAs with clinical data
New Drug (No Clinical)NDA (No Clinical Data)$2,024,348NoReduced fee if relying on previously approved data (e.g., 505(b)(2))
Generic DrugAbbreviated NDA (ANDA)$240,582NoBioequivalence study usually required instead of full trials
BiologicBiologics License Application (BLA)$4,048,695YesFee equivalent to NDA with clinical data (under BsUFA)
OTC DrugMonograph Compliant$0NoNo NDA needed if compliant with an OTC monograph
OTC Drug (NDA Route)NDA (for non-monograph OTC)$4,048,695YesRequired if not eligible under an OTC monograph

FDA Application Timelines for Registering Medicinal Products in the U.S.

The FDA application timelines for the approval of medicinal products in the United States vary depending on the type of product being registered. The approval process is influenced by several factors, including the complexity of the product, the regulatory pathway, and whether the product qualifies for expedited review programs. Understanding the average timelines for different categories of medicinal products—such as new drugs, generic drugs, biologics, and over-the-counter (OTC) drugs—can help pharmaceutical companies plan their development and regulatory strategies. The table below provides an overview of the average FDA review timelines for each product category.

Table 2: Showing Product Category and Approximate FDA Application timelines.

Product CategoryFDA Application TimelineNotes
New Drugs10–12 months (Standard Review)6 months with Priority Review
Generic Drugs10 months (Standard Review)Requires bioequivalence studies
Biologics10–12 months (Standard Review)6 months with Priority Review
OTC Drugs (Monograph)1–2 years (Monograph Compliant)No NDA required if compliant with the monograph
OTC Drugs (NDA10–12 monthsRequires New Drug Application (NDA)

These timelines refer to the FDA’s review period once the application is submitted. It is important to note that the total development timeline, which includes preclinical studies, clinical trials, and preparation of the application, is much longer. Expedited review processes such as Priority Review, Fast Track, and Breakthrough Therapy Designation can help speed up the approval process for eligible products, reducing review times significantly.

Cost-Reduction and Expedited Approval Strategies

Registering a medicinal product in the U.S. is notoriously expensive and time-intensive—but it doesn’t have to be. The FDA offers a range of pathways and programs specifically designed to lower development costs and accelerate regulatory timelines, particularly for small and emerging biopharma companies. From financial incentives like PDUFA fee waivers to expedited review designations that shave months off approval, these strategies can make the difference between a stalled program and a successful launch.

Cost-Reduction Opportunities

The FDA provides several regulatory mechanisms aimed at reducing the cost of bringing a medicinal product to market, especially for startups and emerging biopharma companies. For instance, the Orphan Drug Designation (ODD) is designed to incentivize the development of treatments for rare diseases and conditions. Companies that receive ODD benefit from significant financial incentives, including waivers of Prescription Drug User Fee Act (PDUFA) fees, tax credits covering up to 25% of clinical trial costs, and seven years of market exclusivity following approval[12].


Another cost-saving regulatory route is the 505(b)(2) New Drug Application. This hybrid pathway allows applicants to use publicly available or previously submitted data for an approved product, thereby reducing the need for duplicative clinical studies. By relying on existing evidence of safety and efficacy, the 505(b)(2) process can cut development costs, depending on the product complexity and required bridging studies[13].

In addition, the FDA Small Business Assistance Program offers significant fee waivers and reductions for qualified entities. Companies with fewer than 500 employees may be eligible for a full waiver of the NDA, BLA, or ANDA application fees for their first application submission, along with exemptions from establishment and product fees in some cases. These provisions are intended to lower the barrier to entry for innovation-driven small and mid-sized companies seeking regulatory approval[14].

Timeline Reduction and Expedited Review

Alongside cost-saving initiatives, the FDA also facilitates accelerated access to market through its expedited review programs. The Fast Track and Breakthrough Therapy Designations are available for products that treat serious conditions and demonstrate the potential to address unmet medical needs. These programs offer sponsors enhanced communication with the FDA, rolling review of data sections, and earlier involvement from senior regulatory reviewers.
Among the most impactful tools is the Priority Review designation, which reduces the FDA’s standard review time from 10 months to just 6 months. This faster decision timeline applies to NDAs or BLAs for drugs that offer significant improvements in safety or efficacy over existing therapies[11]. Companies may request this designation at the time of submission, and if granted, benefit from faster feedback and a shorter path to commercialization.


Furthermore, recipients of a Priority Review Voucher (PRV)—often granted for therapies addressing neglected tropical diseases, rare pediatric diseases, or bioterrorism threats—can use the voucher to expedite the review of another product or sell it on the open market. This creates not only regulatory value but also a lucrative financial asset[15].

The Long and Short of Registering a Medicinal Product in the U.S.

Registering a medicinal product in the U.S. is a meticulous process that requires scientific rigor, regulatory compliance, and ongoing safety monitoring. Each phase, from preclinical testing to post-market surveillance, plays a crucial role in ensuring that the drug is safe, effective, and compliant with FDA regulations. By adhering to these regulatory guidelines, pharmaceutical companies can successfully navigate the complex approval landscape and bring innovative, life-saving medications to the public. Remaining updated with FDA requirements and maintaining strict quality standards is essential for successful drug registration and commercialization.

How SEQOVA Can Support Your Medicinal Product Registration

Navigating the complexities of FDA regulatory requirements can be challenging, but SEQOVA provides expert guidance to pharmaceutical companies seeking to register medicinal products in the U.S. From preclinical development to post-market compliance, SEQOVA offers regulatory consulting, clinical trial management, manufacturing compliance support, and submission assistance to ensure a smooth approval process. With extensive experience in FDA requirements, SEQOVA helps clients streamline documentation, mitigate risks, and expedite regulatory approvals.

To have an open discussion about how SEQOVA can support your product registration journey, send us an email.

Interested to learn more about SEQOVA’s insights?, check out our previous article on Basics of Registering Medicinal Product in the EU.

References

  1. U.S. Food and Drug Administration. “Drug Development and Approval Process.” FDA, https://www.fda.gov/drugs/development-approval-process-drugs
  2. U.S. Food and Drug Administration. “Investigational New Drug (IND) Application.” FDA, https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
  3. U.S. Food and Drug Administration. “New Drug Application (NDA).” FDA, https://www.fda.gov/drugs/types-applications/new-drug-application-nda
  4. U.S. Food and Drug Administration. “Abbreviated New Drug Application (ANDA).” FDA, https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda
  5. U.S. Food and Drug Administration. “Biologics License Applications (BLA) Process.” FDA, https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process
  6. U.S. Food and Drug Administration. “OTC Drug Monograph Process.” FDA, https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
  7. U.S. Food and Drug Administration. “Drug Manufacturing.” FDA, https://www.fda.gov/drugs/pharmaceutical-quality-resources/drug-manufacturing
  8. Electronic Code of Federal Regulations. “21 CFR Parts 210 & 211 – cGMP.” eCFR, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
  9. U.S. Food and Drug Administration. “Postmarket Drug Safety Information.” FDA, https://www.fda.gov/drugs/surveillance/postmarket-drug-safety-information-patients-and-providers
  10. U.S. Food and Drug Administration. “FDA User Fee Rates.” FDA, https://www.fda.gov/industry/fda-user-fee-programs
  11. U.S. Food and Drug Administration. “Prescription Drug User Fee Act (PDUFA).” FDA,  https://www.fda.gov/industry/prescription-drug-user-fee-amendments
  12. U.S. Food and Drug Administration. “Orphan Drug Designation.” FDA, https://www.fda.gov/industry/developing-products-rare-diseases-conditions
  13. U.S. Food and Drug Administration. “505(b)(2) New Drug Application.” FDA, https://www.fda.gov/drugs/types-applications/new-drug-application-nda#Types
  14. U.S. Food and Drug Administration. “User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” FDA, https://www.fda.gov/media/131797/download
  15. U.S. Food and Drug Administration. “Priority Review Voucher Program.” FDA, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/priority-review-voucher-prv-program
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