Public Services Division
Databases and Other Resources
Adis Insight includes profiles of drug programs, clinical trials, safety reports, and company deals, written by scientists. New York: Springer; 2015- . Subscription required.
CenterWatch is a source of clinical trials information for both clinical research professionals and patients. Boston: CenterWatch; 1995- .
ClinRegs provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. Bethesda (MD): National Institutes of Health, National Institute of Allergy and Infectious Diseases; 2015- .
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Bethesda(MD): National Library of Medicine; 2000- .
Health Business Elite contains nearly 600 journals dealing with the health care industry, non-clinical aspects of health care, marketing and health care administration. Many have full text links. Ipswich (MA): EBSCOhost; 2009- .
Pharmaprojects (formely called Pipeline) contains detailed profiles of over 50,000 drugs, covering all drugs for all diseases, from the preclinical to commercialization stage. London: Citeline/Informa Health Business; 2007- .Subscription required.
Biologics Regulated Products regulated by FDA Center for Biologics Evaluation and Research (CBER) still regulates allergenics, blood and blood products, cellular and gene therapy, tissue and tissue products, vaccines, and xenotransplantation.
Brody T. Clinical Trials: study design, endpoints, and biomarkers, drug safety, and FDA and ICH guidelines. 2nd ed. Amsterdam: Elsevier/Academic Press; 2016.
Gad SC. Development of Therapeutic Agents Handbook. New York: Wiley; 2012.
Li JJ, Corey EJ, editors. Drug Discovery: practices, processes, and perspectives. Hoboken (NJ): John Wiley & Sons; 2013.
Lynch HF, Cohen IG, editors. FDA in the Twenty-First Century: the challenges of regulating drugs and new technologies. New York: Columbia University Press; 2015.
Medicines in Development, Washington (DC): Pharmaceutical Research and Manufacturers of America; 2013- .
New Drug Applications (NDA) has been the basis of the regulation and control of new drugs in the United States by the Food and Drug Administration since 1938. Every new drug has been the subject of an approved NDA before U.S. commercialization. Other FDA CDER Evaluation applications include:
- Investigational New Drug (IND) Applications. Current federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.
- Therapeutic Biologic Applications (TBA) which regulates monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, therapeutic proteins and recombinant versions of these products, and other non-vaccine therapeutic immunotherapies.
- Abbreviated New Drug Applications (ANDA) for generic drugs.
New Medicines Database of the European Medicines Agency. London: European Medicines Agency; 1995- .
Ng R. Drugs: From Discovery to Approval. 3rd ed. Hoboken (NJ): Wiley Blackwell; 2015.
Plunkett JW. Plunkett’s Biotech & Genetics Industry Almanac. Houston (TX): Plunkett Research; 2000- . Includes listing of Biotech 350 International Companies), as well as, industry information and selective statistics.
Plunkett JW. Health Care Industry Almanac. Houston (TX): Plunkett Research; 1995- . Includes profiles of the Health Care 500 companies, as well as, industry information and selective statistics.
Spilker B. Guide to Drug Development: a comprehensive review and assessment. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins; 2009.
U.S. Food and Drug Administration. Novel New Drugs 2015 Summary. Silver Spring (MD): U.S. Food and Drug Administration; 2016 Jan. 20 p. FDA report includes data on the number of novel drugs brought to market and timelines for the drug review process.