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Empowering Progress Through Transformative Solutions
Explore our commitment to pioneering breakthroughs that advance health and wellness for all.
About Us
Simplifying How You Manage Your Health
We’re excited to unveil our new, easy-to-use platform, thefdapharma.com, where the millions of Americans with conditions like arthritis, COVID-19, and flu can find complete care and resources all in one place.
Innovations
Advancing Research: Prioritizing Patients in Clinical Trial Development
Discover how Pfizer is enhancing clinical trials with streamlined enrollment, emphasis on patient needs, and initiatives to share valuable insights.
Products We Regulate
Foods
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood, and Biologics
Animal and Veterinary
Cosmetics
Tobacco Products
How Drugs Are Made
The medicines available today have taken an average of 12 years to develop. With dedication, creativity, and science, we can significantly cut that time.
What are the stages involved in drug development?
Drug development typically involves the following stages:
- Discovery: Identifying potential compounds that may treat a specific disease.
- Preclinical Testing: Testing on cell cultures and animal models to assess safety and efficacy.
- Clinical Trials: Conducting studies on human volunteers in three phases to ensure safety, dosage, and effectiveness.
- Approval: Submitting data to regulatory authorities (e.g., FDA) for evaluation and approval.
- Manufacturing: Scaling up production to produce the drug in large quantities.
What is the role of chemistry in drug development?
Chemistry is crucial in:
- Designing and synthesizing active pharmaceutical ingredients (APIs).
- Modifying molecular structures to optimize a drug’s effectiveness and minimize side effects.
- Ensuring stability, solubility, and bioavailability of the compound.
How are drugs tested for safety?
Drugs undergo rigorous testing through:
- Preclinical Studies: Assessing toxicity and pharmacological effects in animals.
- Clinical Trials: Progressing through three phases, starting with a small group of healthy volunteers, then expanding to larger populations with the targeted condition.
- Regulatory Scrutiny: Monitoring post-approval for any adverse effects.
What is the difference between brand-name and generic drugs?
- Brand-name drugs: Developed and patented by a specific company; they undergo extensive research and trials.
- Generic drugs: Contain the same active ingredients but are produced after the patent expires, making them more affordable. They must meet the same safety and efficacy standards.
How are drugs manufactured on a large scale?
Drugs are manufactured using:
- Formulation Processes: Converting the active ingredient into a usable form (e.g., tablets, capsules, injections).
- Quality Control: Ensuring each batch meets stringent safety and efficacy standards.
- Good Manufacturing Practices (GMP): Following regulatory guidelines to maintain consistency, purity, and safety in production.
Latest Articles
Science & Innovation
Harnessing the Power of AI to Detect ATTR-CM
Artificial intelligence (AI) has quietly become a part of our daily lives – through personalized recommendations, virtual assistants, or smart devices, we barely notice it anymore.
Science & Innovation
In Search of a New Hemophilia Treatment
Despite significant advancements in hemophilia treatments over the past several decades, balancing management of the disorder while maintaining regular day-to-day activities remains a challenge.
Science & Innovation
Viral vs Bacterial Infections: Different Pathogens, Different Approaches
Learn about the key differences between viral and bacterial infections and the innovative prevention and treatment options being worked on for each type.
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