<P> Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs . Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests . In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13 . Dozens of drugs were eventually suspended or recalled by manufacturers . In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York . </P> <P> Over-the - counter (OTC) drugs like aspirin are drugs and combinations that do not require a doctor's prescription . The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products . Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision like ibuprofen . </P> <P> In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works . This is seen as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and continued as of August 2014 . </P> <P> The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents . These include blood and blood products, vaccines, allergenics, cell and tissue - based products, and gene therapy products . New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs . </P>

What is the role of the fda in drug regulation