solved Instructions for each Discussion Post Provide a response to both

Instructions for each Discussion Post Provide a response to both discussion posts following the outlined criteria: Each post must be 2 paragraphs Each paragraph must be at least 7 sentences Each response must include 1 reference #1 must have a 2-paragraph response #2 must have a 2-paragraph response References listed can’t be used References must in intext references and included at the bottom of each post #1-Caitilin Definition of Combination Product Medical devices, biologics, and/or drugs are combined to allow medications to work effectively in the targeted areas. The primary mode of action (PMOA) determines the product, a device or drug by how it acquires its intended therapeutic effect through metabolism of chemicals (drug) or no metabolism of chemicals required (device) (ASU, 2021). It is the mode of action (MOA) that creates the most important therapeutic action of the combination product (NAFR, 2004). The PMOA includes any effect of the combination product that intends to cure, diagnose, mitigate, treat, or prevent disease or affect the function of the body (NAFR, 2004). Drug or Device For the purpose of this assignment, I chose the asthma inhaler. A metered dose inhaler (MDI) is used for inhaled respiratory medications. It is a pressurized canister of medicine in a plastic holder with a mouthpiece. When using a MDI, only 10% of the medication enters the lungs, the rest gets stuck in the oropharynx or is swallowed (Rees, 2005). It is important for inhaled respiratory medications to absorb directly into lungs and bypass liver metabolism (Rees, 2005). The asthma inhaler is considered a drug due to the drug’s therapeutic effect on the bronchioles’ smooth muscles. The drug requires a device for delivery of medication into targeted areas. Jurisdiction Jurisdiction of combination products depends on the classification of product (drug, device, or biologic) (FDA, 2020). The asthma inhaler PMOA is a bronchodilator of the lungs to make breathing easier. Since its PMOA is a chemical action from a drug, jurisdiction would be under Center for Drug Evaluation and Research (CDER). The Office of Combination Products was established December 24, 2002. FDA 2020 describes the roles of the office as a base for combination product issues, for medical product classification, and assignment issues. It establishes guidance and regulations refining the regulation of combination products. It classifies medical products as a drug, biologic, or device and assigns them to a FDA center. ASU. (2021). Hcr552 medical device combination medical devices. Retrieved from https://asu.instructure.com/courses/93770/pages/mo… FDA. (2020). Jurisdictional information. Retrieved from https://www.fda.gov/combination- products/jurisdictional-information National Archives Federal Registar (NAFR). (2004). Definition of Primary Mode of Action of a Combination Product. Retrieved from https://www.federalregister.gov/documents/2004/05/… -10447/definition-of-primary-mode-of-action-of-a-combination-product Rees J. (2005). Methods of delivering drugs. BMJ (Clinical research ed.), 331(7515), 504–506. https://doi.org/10.1136/bmj.331.7515.504 #2- Jason Question 1: In your own words define a combination product. Currently the United States is the only country that provides a legal definition for a combination product which is described in 21 CFR 3.2 (e) (FDA, 2018). There are two factors that can interact with a device and be classified as a combination product. Those factors include drugs and biologics (FDA, 2018). For something to be considered a combination product the biologic or drug needs to already be regulated for use and packaged in a combination of either drug and device, biologic and device, or drug, biologic, and device. This configuration needs to be used as a delivery method for medical therapy. Question 2: Define the primary mode of action (PMOA) for an Asthma Inhaler. An asthma inhaler is a combination of drug and device. To define the PMOA of an Asthma inhaler, it is important to analyze the mode of action (MOA) for both the device and drug independently. Once the individual MOAs have been determined then the question of whether or not the therapy could be still delivered in the absence of either the drug or the device can be answered (Amor, 2016). This will determine the PMOA. For example, the drug consists of a bronchodilator medication used to relax the smooth muscle in the lungs, and as a result dilates the bronchi which relieves the restricted airways that restrict breathing. The bronchodilator is stored in an aerosol can which disperses the medication under pressure thus releasing the medication. This was tricky for me to answer because the plastic device itself could not open the bronchial airways and relieve symptoms, yet the question remains, could the bronchodilator reach the lungs without the device? Originally, I felt that the inhaler was the PMOA; however, I now believe the medicine would be considered the PMOA because without it, symptoms would continue to persist, and patients would not receive any therapy. Additionally, the canister which contains the medicine under pressure and releases the medicine with force. Question 3: Based on PMOA which center would have jurisdiction: CDHR, CDER, or CBER? Explain why: Because the drug counterpart is considered to be the PMOA, the Center for Drug Evaluation and Research (CDER) has jurisdiction over this combination product (FDA, 2020). This is because the job of the CDER is to monitor the safety of drugs obtained either over the counter or from prescription (FDA,2020). By delegating these safety tasks, the CDER keeps the consumers best interest at the forefront of public health while ensuring an acceptable level of effectiveness. References: Amor, D. (2016. January). How to determine a combination product’s primary mode of action (PMOA). Retrieved from: https://www.meddeviceonline.com/doc/how-to-determine-a-combination-product-s-primary-mode-of-action-pmoa-0001 (Links to an external site.) Food and Drug Administration. (2020, February). Combination product definitions and combination product types. Retrieved from: https://www.fda.gov/combination-products/jurisdictional-updates/jurisdictional-update-metered-dose-inhalers-spacers-and-other-accessories (Links to an external site.) Food and Drug Administration. (2018, February). Combination product definitions and combination product types. Retrieved from: https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types (Links to an external site.) Food and Drug Administration. (2019, June). Combination product definitions and combination product types. Retrieved from: https://www.fda.gov/combination-products/about-combination-products