Pathological Conditions in Older Adults After studying Module 3: Lecture Materials & Resources, discuss the following: Describe and discuss the pathological conditions that might affect the sexual responses in older adults. How and why do you think Nutritional factors, psychological factors, drugs and complementary and alternative medications affect the immune system in older adults.

In completing Writing Assignment #1 for RGA6207 students will have theopportunity to “reverse translate” an FDA approved product insert and otherdocumentation associated with approval of a pharmaceutical or biologic productback to the information submitted by the manufacturer in Module 1 of an eCTDsubmission. As discussed during Week 3 of the course, the required content for theUS version of Module 1 is described by v2.3.2 of FDA’s Comprehensive Table ofContent Headings (11/1/2018). This document was included in your BlackboardReading Materials folder in Week 3. Specific instructions are as follows:• Search FDA’s available database(s) to identify and select an FDA approvedpharmaceutical or biologic product that received final approval on or afterMay 1, 2017.• Locate the approved product insert, as well as any other regulatorydocumentation associated with the product’s conditional marketing approval• Provide a description of the information that would likely have beensubmitted in the following sections of CTD Module 1, per the instructionsoutlined in v2.3.2 of FDA’s Comprehensive Table of Content Headings(11/11/2018):- 1.14 Labeling- 1.15 Promotional Material- 1.16 Risk Management Plan- 1.17 Post-Marketing Studies- 1.18 Proprietary NamesYour description should summarize the information that you are able toobtain on your conditionally approved product from the FDA website, as wellas from general Internet-based sources. Internet based sources can beparticularly useful to identify promotional materials utilized by productmanufacturers to market the pharmaceutical or biologic product. The FDA’sOffice of Prescription Drug Promotion (OPDP) can often be helpful in thisregard.• From a holistic perspective, please provide an analysis of the riskmanagement issues that might arise from application of FDA pre- and post-market regulations to your product selection. Please include this as part ofyour description of M1 section 1.16.Also, please ensure that your submission includes the following information for yourchosen product1) Date of approval of the product2) A detailed description of the product3) Information regarding any FDA forms used in the marketing of the product4) What competitor versions of the product are available5) A brief synopsis of whether the product chosen is marketed in other globalmarkets (i.e any of the EU5 - Germany, the UK, Italy, France, Spain, Japan,Canada)