Pharmaceutical Drugs: Approval Timelines and the FDA

The journey from laboratory discovery to pharmacy shelf is a complex and often lengthy process in the United States. The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring that pharmaceutical drugs are safe and effective before they reach the public. However, the traditional approval timelines have come under scrutiny, especially when patients with rare or life-threatening conditions await new treatments.

What Is The Standard FDA Approval Process?

Typically, the FDA’s drug approval process spans 12 to 15 years and involves several critical phases:

1. Preclinical Research: Laboratory and animal studies assess the safety and biological activity of the compound.
   
2. Investigational New Drug (IND) Application: Before human trials begin, researchers must submit an IND application detailing the drug’s composition and manufacturing, and plans for testing in humans.
   
3. Clinical Trials:
   
   • Phase 1: Tests safety and dosage in a small group of healthy volunteers.
     
   • Phase 2: Explores efficacy and side effects in a larger patient group.
     
   • Phase 3: Confirms effectiveness, monitors side effects, and compares the drug to commonly used treatments in large populations.
     
4. New Drug Application (NDA): If clinical trials demonstrate the drug’s safety and efficacy, an NDA is submitted for FDA review.
   
5. FDA Review: The FDA evaluates the NDA, which can take 6 to 10 months, depending on the review priority.
   
6. Post-Marketing Surveillance: After approval, the FDA continues to monitor the drug’s performance in the general population according to according to Leigh Ann Anderson, PharmD in 2024.l

This rigorous process ensures drug safety but can delay access to potentially life-saving treatments.

What Is the Timeline For FDA Approval?

The FDA drug approval timeline is listed below.

1. Preclinical Research – 1–2 years
   
2. IND Application Review – 30 days
   
3. Clinical Trials:
   
   • Phase 1 – ~1 year
     
   • Phase 2 – ~2 years
     
   • Phase 3 – ~3–4 years
     
4. New Drug Application (NDA) Review – 6 to 10 months (Priority Review: 6 months; Standard: 10 months)
   
5. Post-Marketing Surveillance – Ongoing after approval

Total Time: Approximately 10–15 years. Expedited pathways can shorten this.

What Are Ways To Speed Up The FDA Approval Process for Urgent Needed Medicine?

Recognizing the need for faster access to critical therapies, the FDA has established expedited programs:

• Priority Review: Reduces the FDA review period from the standard 10 months to 6 months for drugs that offer significant improvements in treatment.
  
• Breakthrough Therapy Designation: Provides intensive FDA guidance for drugs showing substantial improvement over existing therapies based on preliminary evidence.
  
• Fast Track Designation: Facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need.
  
• Accelerated Approval: Allows earlier approval of drugs for serious conditions that fill an unmet medical need based on a surrogate endpoint.

These pathways aim to bring therapies to patients more quickly, especially in areas with no existing treatments.

Dr. Shoshana Shendelman’s Perspective on FDA Modernization

Dr. Shoshana Shendelman, a scientist and entrepreneur, has been vocal about the need to modernize the FDA’s approval processes. In her article “Permit Bureaucracy Means People Die Waiting for Therapeutic Advances,” she highlights several concerns listed below from a Real Clear Markets article in March 2025.

• Outdated Regulations: Dr. Shendelman argues that FDA guidelines have not kept pace with scientific advancements, such as AI and gene editing. She emphasizes the need for regulatory frameworks that reflect current technologies.
  
• Bureaucratic Delays: She points out that the FDA’s linear and prolonged review processes can hinder the timely availability of treatments, particularly for rare diseases affecting over 30 million Americans, 95% of whom lack approved therapies.
  
• Human Impact: Dr. Shendelman stresses the importance of FDA reviewers engaging with patients to understand the real-world implications of delayed approvals (Real Clear Markets Dr Shoshana Shendelman March 2025). She believes that connecting decision-makers with those awaiting treatments can drive more empathetic and timely decisions.

Her advocacy underscores the balance between ensuring drug safety and providing timely access to essential medications.

The Path Forward During A Pivotal Time for the FDA

While the FDA’s stringent approval process is designed to protect public health, there is a growing consensus on the need for reform to address urgent medical needs without compromising safety. Incorporating modern scientific tools, streamlining bureaucratic procedures, and fostering patient engagement are steps that can enhance the efficiency of drug approvals.

As the medical landscape evolves, so too must the regulatory frameworks that govern it, ensuring that patients receive timely access to innovative and effective treatments.