The smoothened molecule inhibitor is known as PEZ2020D or “SmoothSkin." Smoothskin is a synthetic molecule that is involved in the stem cells of mammals inhibiting the effects of stem cells, thereby leading to loss of hair. This potent molecule can be successfully used to get rid of unwanted hair, thereby proving to be a viable beauty and skincare product.
This paper looks into the five-step regulatory strategy that PharmaEZ will use to get US FDA approval in order to put the product into the market. Their latest product is PE2020D (Smooth Skin). Smoothskin is a signalling molecule that was covered by PharmaEZ.
The company is currently interested in marketing PEZ2020D as a facial cream for removing facial hair. Once PEZ2020D is approved by the FDA and out on the market, this drug will help many patients who are dealing with mild to severe skin disorders and generate a big revenue that could offset the declining sales due to patent expiration.
A Goal – a step by step strategy for obtaining US regulatory approval for PEZ2020D (Smooth Skin).
a) A regulatory strategy for US approval
(1) Preclinical trials
Preclinical trials allow scientists to vet the safety and effectiveness of drugs and other substances prior to testing them on human subjects. The reason this process is necessary for PharmEZ is directly linked with the need for the FDA to prove that the SmoothSkin molecule is safe to be tested on real human subjects. These studies are often undertaken in the lab.
(2) Clinical Trials
Clinical trial evidence may be requested during the certification process, but otherwise, the procedure is really similar to the US 510(k) process. It is possible during the review process that a clinical trial could be requested in order to provide additional support to the application in cases where there have been changes made to the product that could affect the intended use, or the material or composition of the product, or major changes to the design of the product that may affect its safety and effectiveness.
(3) NDA application for FDA approval for marketing in the US
At the point when a substance is prepared for clinical investigation, yet before any testing in human subjects, the drug engineer is obligated to embrace the FDA. This procedure starts when the drug's support (typically the drug producer or wholesaler) applies for the new drug (NDA) with the office. Government law necessitates that a drug is the subject of an endorsed promotional application for it to be lawfully dispatched across state lines. An affirmed NDA application furnishes the engineer with a specialized exclusion to this government regulation so clinical agents can disseminate a drug to various investigation habitats over the US.
(4) Description of the meetings that will be scheduled with the FDA and when in the process, they will occur.
A 510(k)-premarket notice ought to be submitted to exhibit generous identicalness, and our organization must stick to the general controls, including yearly foundation enlistment, product posting, legitimate product naming, great assembling practices.
(5) Design post-marketing surveillance for potential adverse events.
SmoothSkin is a product for indications that are common and would not be classifiable as a HUD, as it would be a treatment option for more than 6,513 individuals in the US annually. Therefore, there will be no orphan device application routes available for SmoothSkin.
b) Potential Side Effects
(1) Types of side effects predicted for Smoothskin
There two types of side effects, namely irritation of the skin and lack of appetite.
(2) Conditions inhibitors and agonists of Smoothened signalling are currently being tested. Inhibitors include penicillin, aspirin, and protease.
(3) Types of side effects have been reported.
Two types of side effects have been reported namely irritation of the skin and lack of appetite
(4) Types of side effects have been reported for naturally occurring inhibitors and agonists of Smoothened signalling.
Two types of side effects for naturally occurring inhibitors include irritation of the skin and lack of appetite
(5) Types of preclinical and clinical tests would be possible and appropriate to rule out serious potential side effects. The lab attendant will check how the drug is metabolized, distributed, absorbed, then disregarded in the body.
c) Timeline for the entire process – 7 years
B Some anticipated problems
1. Agreement on one regulatory approach
2. Defining the focus of each objective
3. Finding the appropriate literature
I. Introduction & Background
A Background Information on Company
PharmEZ is a global pharmaceutical company headquartered in New York, New York. The company was founded by Charles Pfizer in 1849. The company strives to be one of the top pharmaceutical companies in the world and focuses on developing, manufacturing, and commercializing best-in-class medicines for better patient care. Our company has a portfolio of top medical products in a variety of categories, including pharmaceutical, medical devices, biologics, and consumer health fields.
B How this project fits into the overall research/business strategy
With the help from the latest acquisition and continuous developing plans for the pipeline, PharmEZ recently designed a new synthetic small molecule that is a potent Smoothen Inhibitor (PEZ2020D or SmoothSkin). The company is currently interested in marketing PEZ2020D as a facial cream for removing facial hair. Once PEZ2020D is approved by the FDA and out on the market, this drug will help many patients who are dealing with mild to severe skin disorders and generate a big revenue that could offset the declining sales due to patent expiration.