Regulatory Support for
Medicinal Products in USA
Comprehensive FDA regulatory support for pharmaceutical sponsors navigating drug approval — from IND submissions through NDA, ANDA, and 505(b)(2) applications.
💊 FDA Drug Approval Pathways
Investigational New Drug — Begin Clinical Trials
New Drug Application — Full Approval
Relies on Existing Safety & Efficacy Data
Abbreviated NDA — Generic Drug Approval
World’s Largest Pharmaceutical Market
The United States accounts for nearly half of the global pharmaceutical market, with a projected market share of 43.72% in 2023.
✅ NDA
✅ ANDA
✅ 505(b)(2)
⚠️ Key Regulator: The Food and Drug Administration (FDA) is the primary regulatory agency responsible for drug approval in the United States, with CDER overseeing most drug applications.
The US Drug Approval Process
The Center for Drug Evaluation and Research (CDER), a division of the FDA, oversees the approval process for most drugs. The process begins with the submission of an Investigational New Drug (IND) application after preclinical trials demonstrate the drug’s safety.
The Pre-IND assessment allows sponsors to discuss key issues with the FDA — including animal research design, clinical trial protocols, and manufacturing controls. The FDA typically approves INDs within two years.
CDER aims to review and act on at least 90% of NDAs for standard drugs within ten months, making timely and accurate submission critical to your programme timeline.
Overview of the Drug Approval Process
A structured pathway from preclinical research to full FDA approval — covering IND, NDA, ANDA, and 505(b)(2) submissions.
Preclinical Research
Before human testing, the drug undergoes laboratory and animal studies to evaluate safety and biological activity. Positive results allow the sponsor to proceed to an IND application.
Pre-IND Stage
Pre-IND Assessment
Sponsors discuss animal research design, clinical trial protocols, and manufacturing and control of the investigational drug with the FDA before submitting the IND application.
FDA Meeting
IND Application Submission
The IND includes forms, protocols, chemistry, manufacturing and control (CMC) information, and pharmacology and toxicology data. The FDA typically approves INDs within two years.
IND Requirements
Clinical Trials — Phase I, II & III
Clinical trials are conducted in three phases to evaluate safety, dosage, efficacy, and side effects in progressively larger human populations before an NDA can be filed.
Phase I / II / III
New Drug Application (NDA)
The NDA includes all animal and human data, analyzed data, pharmacokinetics, manufacturing details, and the anticipated label. Two copies — archival and review — must be submitted.
NDA Submission
505(b)(2) Application
Used when some supporting data was not generated by the applicant or when they lack the right of reference. Applicable for NCEs and changes such as a new route of administration.
505(b)(2)
Abbreviated New Drug Application (ANDA)
Filed for previously approved drugs (generics). ANDAs rely on the FDA’s prior finding of safety and effectiveness and include only information supporting the change from the approved product.
Generic Drugs
CDER Review & Risk-Benefit Analysis
CDER reviews all preclinical and clinical reports and performs a risk-benefit analysis. It aims to review and act on at least 90% of standard NDAs within ten months.
FDA Review
FDA Approval & Post-Market Compliance
Upon approval, the sponsor receives an FDA approval letter. Ongoing post-market surveillance, labeling compliance, and lifecycle management obligations must be maintained.
Post-Approval
NDA vs ANDA vs 505(b)(2) — Which Applies?
Choosing the correct application type is critical to a successful and timely FDA drug approval strategy.
NDA — New Drug Application
For new drugs completing all three phases of clinical trials
Submitted after successful Phase I, II, and III clinical trials
Must include all animal and human data and analyzed results
Requires pharmacokinetics data, manufacturing details, and anticipated label
Requires two copies: archival copy and review copy
CDER targets review of 90% of standard NDAs within ten months
Full risk-benefit analysis conducted by CDER before approval
ANDA & 505(b)(2) Applications
For generic drugs and applications relying on existing approved data
ANDA filed for previously approved (generic) drug products
ANDAs rely on the FDA’s prior safety and effectiveness findings
505(b)(2) used when applicant lacks right of reference to all data
Applicable for NCEs and changes such as new route of administration
505(b)(2) follows the same approval process as a standard NDA
CDER is responsible for approval of all generic drugs via ANDAs
RABT’s Pharmaceutical Regulatory Services
Comprehensive support across every stage of the US FDA drug approval lifecycle — from IND through post-approval compliance.
IND Application Support
End-to-end preparation and submission of Investigational New Drug applications including CMC, pharmacology, and toxicology sections.
Pre-IND Meeting Preparation
Strategy and briefing document preparation for Pre-IND meetings with FDA covering trial design, CMC, and regulatory pathway alignment.
NDA Compilation & Submission
Full NDA dossier preparation including archival and review copies, clinical summaries, and submission management per FDA requirements.
505(b)(2) Application Support
Strategic guidance and dossier preparation for 505(b)(2) applications for NCEs and products relying on existing approved data.
ANDA Submissions — Generic Drugs
Abbreviated New Drug Application preparation and submission management for generic drug approvals via CDER.
CMC Documentation
Chemistry, Manufacturing and Controls documentation for IND, NDA, and ANDA submissions aligned with FDA guidance.
Clinical & Preclinical Data Analysis
Review and analysis of preclinical and clinical study reports to support risk-benefit assessments in NDA submissions.
Labeling & Prescribing Information
Development and review of drug labeling, package inserts, and prescribing information compliant with FDA regulations.
Post-Approval Lifecycle Management
Ongoing support for post-approval changes, supplemental applications, and FDA compliance maintenance after drug approval.