ISSN: 2041-6792

Clinical Investigation

Research Articles Of New Chemical Entities

 Infectious diseases have been problematic and devastating to human lives since centuries. A large number of vaccines and infectious disease treatments are available today. However, infectious diseases still pose serious threats to patients because of the development of antibiotic resistance and the emergence of new infectious diseases, for example, since 1970s about 40 new infectious diseases have been discovered including swine flu, avian flu, MERS, and SARS. According to the literature, antibiotic resistant infections affect more than 2 million American people annually, cause about 23000 deaths annually, and account for $20 billion in direct health care costs annually. Therefore, continuous efforts are required to develop new drugs for the treatment of infectious diseases. However, for pharmaceutical research companies, bringing new treatments for infectious diseases to the market is a challenging process because of the development of antibiotic resistance. Once a treatment has developed resistance to an infectious disease, medical practitioners start prescribing new treatments available in the market. This leads to financial loss to pharmaceutical research companies. Accordingly, on July 9, 2012, the Generating Antibiotic Incentives Now Act (GAIN Act) was signed into law by the President of U.S.A. as part of the U.S. Food and Drug Administration Safety and Innovation Act. The GAIN Act grants five years of exclusivity for those new antibiotics designated under the law as a “Qualified Infectious Disease Product (QIDP). The QIDP has been defined as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections. During the exclusivity period antibiotics having QIDP designation can be sold without generic competition. 

High Impact List of Articles

Relevant Topics in Clinical