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Biofrontera, Inc. (BFRI)
NASDAQ:BFRI
1H Incubation Photodynamic Therapy (Pdt) (Ala-Pdt, Ameluz®-Pdt), 3H Incubation Photodynamic Therapy (Pdt) (Ala-Pdt, Ameluz®-Pdt)
Acne Vulgaris
Phase II
Active Not Recruiting
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults
Sep 09, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Biofrontera, Inc. (BFRI) have in its pipeline
BFRI is currently developing the following drugs: 1H Incubation Photodynamic Therapy (Pdt) (Ala-Pdt, Ameluz®-Pdt), 3H Incubation Photodynamic Therapy (Pdt) (Ala-Pdt, Ameluz®-Pdt). These drug candidates are in various stages of clinical development as the company works toward FDA approval.