Regulatory Support for
Pharmaceuticals in USA
The United States represents the largest continental pharma market worldwide and holds a major share of the global market. The U.S. is expected to retain its leading position in the global pharmaceuticals market with a market share of 43.72% in 2023, improving on its market share compared to 2017. The FDA is the main regulatory body that handles drug approval in the United States.
🔍 FDA Drug Approval Pathways
Investigational New Drug — Clinical Trial Authorization
New Drug Application — Full Premarket Review
Bridging Application — Relies on Existing Data
Section 505(j) — Generic Drug Approval
US FDA Pharmaceutical & Drug Registration
All companies planning to market a pharmaceutical product in the United States need to obtain drug approval from the US FDA.
✅ NDA
✅ 505(b)(2)
✅ ANDA
⚠️ Key Requirement: The FDA approval process begins only after the submission of the Investigational New Drug (IND) application. A New Drug Application (NDA) can be filed only when the drug successfully passes all three phases of clinical trials.
The US FDA Drug Approval Process Explained
The Food and Drug Administration (FDA) is the regulatory body for drug approval in the USA and is responsible for protecting and promoting public health.
The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
The FDA approval process begins only after the submission of the Investigational New Drug (IND) application. If the results prove safe in the preclinical trials, the sponsor can submit an IND application with the FDA to start clinical trials in humans. The sponsor is responsible for the submission of the IND application.
Overview of the IND & NDA Approval Process
A structured pathway to US market entry for pharmaceutical products — from pre-IND assessment through clinical trials, NDA review, and marketing authorization.
Organize a Pre-IND Assessment
A Pre-IND assessment can be organized with the FDA to deliberate multiple issues such as the design of animal research required to support clinical studies, the intended protocol for conducting the clinical trial, and the chemistry, manufacturing, and control of the investigational drug.
Pre-IND
Submit the IND Application
If the results prove safe in the preclinical trials, the sponsor submits an Investigational New Drug (IND) application to start clinical trials in humans. Requirements include FDA forms 1571, 1572, and 3674, protocols, chemistry, manufacturing and control information, and pharmacology and toxicology information.
IND Forms
FDA Review Team Assignment
An applicant with all the required information applies to the FDA. On receiving the application, the FDA forwards it to the review team.
FDA Review
30-Day Safety Review
Within 30 days after the IND sealing date, the review team provides its positive or no response, after which the sponsor can start clinical trials.
30 Days
Conduct Clinical Trials
Within 60 days from announcing the IND, the sponsor shall submit the reports of clinical trials. The sponsor shall conduct a meeting one month before ending Phase II trials.
Phase I–III
Initiate Pre-NDA
After the completion of Phase III trials successfully, the sponsor shall initiate the pre-NDA 9–12 months before NDA submission. Generally, the FDA approves the IND within two years, though this timeline may range from several months to years.
9–12 Months
Pre-NDA Meeting
The process starts with a Pre-NDA meeting, which addresses the submission of the NDA including issues such as format and content.
Pre-NDA Meeting
NDA Submission & Filing
A New Drug Application (NDA) can be filed only when the drug successfully passes all three phases of clinical trials and comprises all animal and human data, analyses, the pharmacokinetics of the drug, its manufacturing, and the anticipated label. Two copies are required — an archival copy and a review copy.
NDA Filing
Filing Decision by CDER
The FDA has 60 days to decide whether to accept the file for review. The FDA forwards the file to CDER, which evaluates eligibility for filing; if found eligible, it accepts the application and forwards it to the FDA reviewer team.
60 Days
FDA Facility Inspections
The FDA conducts inspections of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts.
Inspection
CDER Review
Within 180 days, the reviewer team submits the report to CDER. The preclinical, clinical reports, and risk-benefit analysis are studied at the Center for Drug Evaluation and Research.
180 Days
Marketing Authorization
If the review result is positive, the FDA issues marketing authorization to the sponsor, allowing the drug to be marketed in the United States.
Approved
NDA 505(b)(2) vs ANDA — Which Pathway Applies?
Understanding the right submission pathway is critical to a successful FDA regulatory strategy.
NDA 505(b)(2) — Bridging Application
For applications relying on data not conducted by or for the applicant
Relies on one or more investigations not conducted by or for the applicant, without a right of reference or use
Example: a change in the route of administration, such as from an intravenous to an intrathecal route
Can be submitted for an NCE when part of the data is from studies not conducted by the applicant, often from published studies
May rely on the agency’s finding of safety and effectiveness of a previously approved product, plus data supporting the change
Approval process follows the same as NDA approval; CDER reviews ≥90% of standard NDAs within ten months
Eligible for 3 years of Hatch-Waxman exclusivity, or 5 years for a new chemical entity
ANDA — Abbreviated New Drug Application
For generic drugs submitted under section 505(j)
Overseen by the Office of Generic Drugs (OGD), ensuring generics are safe, effective, and high-quality
FDA-approved generic drugs account for about 90 percent of prescriptions filled in the United States
The sponsor applies for the ANDA to the FDA under section 505(j)
Full Approval: all valid patents and exclusivities for the reference listed drug (RLD) are expired or legal issues are settled
Tentative Approval: meets all quality, safety, and efficacy standards but cannot yet be marketed due to patents or exclusivity
An Acceptance / Refuse to Receive (RTR) letter is issued based on the completeness of the ANDA
FDA Drug Regulatory Services We Provide
Comprehensive support across every stage of the US FDA pharmaceutical regulatory lifecycle.
IND Applications
Investigational New Drug (IND) Applications.
New Drug Applications
New Drug Applications (NDAs).
ANDAs
Abbreviated New Drug Applications (ANDAs).
Biologics License Applications
Biologics License Applications (BLAs).
Drug Master Files
Drug Master Files (DMFs).
U.S. Agent
Act as a US Agent for foreign applicants.
Pre-Submission Administrative Activities
ANDA number request, labeler code request, establishment SPL submission and GDUFA cover sheet generation.
eCTD Dossier Submission
Compilation and submission of the dossier in eCTD format.
Development & Manufacturing Consultation
Consultation during the ongoing, completed developments and manufacturing of the finished product.
Amendments
Amendments (query responses and unsolicited information) compilation and submission to all types of submissions.
Post-Approval & Life Cycle Management
Post-approval (CBE-0, CBE-30 & PAS) and life cycle management (annual report) compilation and submission.