The pharmaceutical industry produces, discovers, creates, and sells pharmaceutical products or drugs intended to be administered directly to humans, with the primary purpose of healing them, diagnose them, treat them, or relieve their symptoms. Pharmaceutical industries may exclusively deal in medical devices and generic or brand medicines. They may also deal in biotechnology and animal health. Some pharma companies focus on the manufacturing of vital medicines that are vital to human survival such as HIV/AIDS, malaria, hepatitis, pneumonia, and chickenpox.
Biotechnology is the study of how living organisms can be manipulated to produce desirable or useful products. This includes genetic engineering, cell and tissue culture technologies, genetic approaches, transcriptomics, and transgenic technologies. Some pharmaceutical companies focus on the development of pharmaceutical products which can address a disease holistically, including treating the physical and other symptoms of the disease. Others focus on the design of drugs which target a single symptom, for example an injection of a small number of cells or molecules which can kill a single virus or bacteria. There are numerous examples of pharmaceuticals that have developed drugs that relieve symptoms associated with very serious diseases like AIDS and cancer.
The Food and Drug Administration or FDA regulates the production of drugs in the United States. Together with the Center for Drug Evaluation or CED, the FDA regulates the amount, form, and amount of ingredients used in drugs and cosmetics. The FDA defines the four basic areas of regulation of the cosmetics and pharmaceutical industry. The four areas are: safety, effectiveness, purity, and control. The Food Drug and Administration or FDA ensures that drugs and cosmetics sold in the United States are safe, effective, and properly packaged.
With the FDA, the manufacture of drugs is subject to the most stringent requirements. This includes ensuring that the strength of a medicine is consistent, the chemical properties are consistent, and the correct dosage is provided. Because of this, there are rigorous controls exercised on the new drugs before they are released for marketing. The pharma researchers play an important role in the review, development, and testing of these new products before they are released into the market. Their work is crucial to the success of the new product. Some of the areas of pharma research that are conducted by the FDA include the pre-clinical development of the new products, registration and labeling of the medicines, regulatory submission, and compulsory registrations.
The chief objective of the FDA is to protect the public from the risks posed by unsafe and ineffective medicines. The agency also aims to ensure that the public gets the access to affordable quality healthcare. For this, the FDA sets high standards of quality and manufacturing controls for pharmaceuticals. In addition, the agency helps the pharma industry to remain within the letter of the law by imposing tough penalties for violations of the regulations.
The main functions of the FDA are to monitor and enforce the implementation of the provisions of the Controlled Substances Act and the Biotechnology Industry Organization (BPI) Act. These acts were enacted to govern the manufacture, development, processing, distribution, and sale of prescription drugs and medical devices in the United States. These laws have helped to maintain the availability of prescription drugs and medical devices to the benefit of the patients. However, these acts do not allow the pharmaceutical companies to introduce a new drug without a medical necessity. Thus, the importance of FDA is indispensable in the treatment of any harmful or risky medical device or medicine that could threaten the lives and health of the patients.