Role of CDER

Question: Describe about the Role of CDER? Answer: Introduction: CDERs mission is to promote and protect public health to ensure the usage of drugs is safe and effective according to their intended use. CDER also ensure the availability of the drugs to the patients and they must match the quality standards. CDER is a part of U.S Food and drug administration (FDA). Including generic drugs and biological therapeutics, CDER do prescription on drugs and also regulates over-the-counter. CDER regulates various other things as well other than medicine. For example, sunscreens and dandruff shampoos that can be considered as drugs and others as well like fluoride toothpaste and antiperspirants. CDERs basic business model: CDERs mission can be described in terms of three long-term objectives for human drugs, which are identified in Strategic priorities given by FDA (2013-2017). CDERs mission is to Make promotion on public health to ensure the availability of effective and safe drugs. Protection of the public health by promoting the safe usage of marketed drugs. The protection of the health of the public by ensuring the integrity and quality of the products that are marketed. All these long term objectives do implementation on FDA responsibilities for human drugs, as specified in the act upon Food Drug and Cosmetic (CDER issues guidance against use of certain phthalates, 2012). CDER intensely pursue the objectives and fundamental goals, such as- CDER conducts science based premarket review so that it can ensure the drugs can be marketed to the public are effective and safe. CDER do identification and development of the new scientific models, methods and tools to improve the safety, quality, efficiency and predictability of new drug development. CDER also do promotion of health and patient awareness about drug benefits and the associated risk through effective communication on drug information. CDER conduct the post-market surveillance to detect new safety signal at early stage. CDER provide promotion of safe of use of the drug. CDER ensure the security of the global supply chain to ensure the drug integrity. CDER ensures that the distribution and manufacturing of drugs with a better quality standard. Improve the drug quality and its capacity through the extended use of risk-based methods. CDER do the promotion to increase awareness of public and stakeholder about the drug integrity and quality through the effective consumer communication(Highlights of US CDER drug safety activity in 2003, 2004). CDERs operating model: Science: Science includes portfolio for management and development of a regulatory research to maximize the return on investment of applied research, so that the inherent uncertainties in manufacturing and development can be reduced. Policy: Policies include the development of the CDER guidance and regulations related to the three core areas- committing and drafting on legislation, leading the response and analysis to the citizen petitions and making other coordination policies with other international and federal policy- making bodies and other FDA offices (Jacobs and Brown, 2015). Planning: Planning includes the trend analysis, which affects the resource requirements and CDER mission, program plan development and performance metrics, implementation done on the identified program initiative, program performance evaluation and conduct operation analysis. Management: Management includes systems and its processes for hiring, training, paying, assessing and retention staff. Administrative management tasks include formulation of center budget, execution and requests on budget, requirements on planning facility and addressing associated issues with the current facility operations. Information management/Information Technology: It includes developments of the infrastructure, standards, process and tools to enable full e-regulatory oversight throughput drug life cycle. This area includes implementation and development of long-range plans to manage information, including a process of co-evolving business operation and enable informatics (Lu, 2007). Communication: Communication includes the set of collected information, based on which outside stake holders need to know and want to know about the safe use of human drugs and related information about them. This activity also looks for the FDAs activity of protecting public health and also to help in product innovation and the advance drug development program. Range of activities include public roll-out of the information on newly taken CDER regulatory initiatives and also make use of other information and full range of media and other information channel to enable relevant and good understanding of human drug issues(Schwieterman, 2006). Conclusion: With all the above discussion it is recognized that the health professional, consumers, patients and most importantly external stake holder play a critical role in CDERs effort to achieve mission and vision to set up awareness of healthy usage of drugs. CDRE helps to give shape to the management and implement programs that leverage the FDA efforts and ultimately it is improving public health. References CDER issues guidance against use of certain phthalates. (2012). Reactions Weekly, 1432(1), pp.2-2. CDER proposes changes to improve safety of compounding. (2013). Reactions Weekly, 1454(1), pp.4-4. Comments from the Survey by CDERCBER Scientists. (2006). Oncology Times, 28(16), p.12. Hastings, K. (2002). Implications of the new FDA/CDER immunotoxicology guidance for drugs. International Immunopharmacology, 2(11), pp.1613-1618. Highlights of US CDER drug safety activity in 2003. (2004). Reactions Weekly, NA;(1005), p.3. Woodcock, J. (2014). Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov, 13(11), pp.783-784.