Development Of Generic Product And Approval

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

The report analyzes three options to record the transfer of the in process research and development project Drug X from Bust-a-Knee to Pharmers. Based on the analysis, we recommend Options #3 as the approach to record the journal entries at the date of transfer.

The scope of the drug development process is defined to prepare the audience to understand the role of regulatory affairs professionals. Responsibilities and roles of regulatory affair’s professional are explained and described in the presentation. However, the functional role of a regulatory affair professional in cross-functional area has not been included. Addressing the Importance of communication skills and experience can provide added incentive to the reader for personality or characteristic of the profession. The presentation is direct to the point and delivers basic understanding of the role to the audience. However, it can be expanded to include additional details such as educational prerequisite and job characters to describe the professional

This industry has monopolized drug distribution to sustain and control high cost of the brand name prescription drugs. These brand name drugs were covered under patent protections, which stipulate that only that pharmaceutical company awarded coverage can manufacture, market and eventually profit from that specific drug. As long as the patent protections exist, these drugs cannot be sold as generic brands by other companies. The regulations outlined in the PPACA, however, challenged these patents to allow a more competitive field, thus dropping the cost of drugs and sales of brand named prescriptions. This lowered the revenue of high cost drugs and opened accessibility for lower cost options. The PPACA continued to further impose regulations, even on biologic pharmaceutical products. These products, which are versions of the original biologic products “that have the same mechanism of action in the body and are used for the same clinical indication but are not identical to the original product (variously referred to as the reference, pioneer, or innovator product)” (Health Policy Brief, 2013, para 5).  The reform also included the Biologics Price Competition and Innovation Act (BPCIA), which encourages to allow competition, as the regulation of the patent protections, in the market for biologic

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

Before any biopharmaceutical company can begin to manufacture a desired product, the company is required by law to establish an adequate facility to support a safe and efficient manufacturing process. The US Food and Drug Administration (FDA) department under the authority of the Federal Food, Drug, and Cosmetic Act determines whether or not a specific manufacturing facility is approved. Furthermore, companies must adhere to the Good Manufacturing Practice Regulations (GMP) specifically those described in ICH Q7 in order to effectively fulfill FDA requirements. The fundamental purpose of the regulations beforehand is to accomplish a system that ensures products are consistently produced and controlled to the highest standards and thus prevent human safety risks that may not be reduced through testing the final

E. Generic drugs can have different manufacturers, which mean they can also have different inactive ingredients in it.

The FDA’s Center for Drug Evaluation and Research (CDER), the largest of six FDA centers, plays an essential rule in public safety and health by ensuring that the available drugs in the market are safe and effective for their proposed use. CDER mission is to regulate new drugs, including over-the-counter and prescription treatments, and provide doctors and patients with necessary information to use these drugs wisely and efficiently. CDER, however, is not responsible for testing drugs even though the Center Office of Testing and Research partially investigates areas of the drug quality, safety, and effectiveness.

When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my mom or dad how come the doctors don’t get together and make a “miracle” drug that could heal anything and everything. It wasn’t until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother’s diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

The FDA will not approve a generic drug unless the manufacturer can prove that the drug has the same active ingredients at the same dosage. This means that you can trust the efficacy of generics just as you would a brand-name drug, since they undergo the same rigorous screening.

The classification is vital in establishing the future plan of the product as well as the regulations needed in order to receive FDA approval for the product. This will be done by looking over the Food and Drug Administration website. The product claim must be established in order to establish a concise focus of the product. There will be repetitive and tedious edits in order to establish a thorough statement. The regulatory plan and healthcare developmental plan are implemented in order to create a detailed and complete outline of every step needed to be taken in order to gain approval of the product. The detailed process can be found in the methodology steps but it includes working with the federal

1. The following is a list of skin types and conditions. Divide them into two groups: skin types and skin conditions: provide five characteristics for each type and condition. Explain what the product recommendation would be and indicate what the treatment objective would be for each one SUN DAMAGED, COUPEROSE, DEHYDRATED, ACNE, CONGESTED, COMBINATION, DRY, NORMAL, SENSITIVE, OILY, MATURE Skin type: Normal, dry, oily, sensitive, combination, mature. Skin condition: Couperose, dehydrated, acne, congested, sun damaged.

As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).

The finished product need to contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation and are of the purity required.