The FDA Approval Process: Overview, Pros, Cons, and its Effect on Share Prices; Analyst Report by BrokerBank Securities, Inc. - NBC12 - Richmond, VA News

The FDA Approval Process: Overview, Pros, Cons, and its Effect on Share Prices; Analyst Report by BrokerBank Securities, Inc.

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact

SOURCE BrokerBank Securities, Inc.

NEW YORK, June 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA), based in Silver Spring, Maryland  provides a variety of public health services in the United States through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter (OTC) pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary products. When most people refer to the FDA, they are likely speaking about the Center for Drug Evaluation and Research (CDER), which is the agency's largest center and is tasked with ensuring that drugs marketed in the US are both safe and effective. The CDER is responsible for new drugs, generic drugs and OTC drugs.

New drugs cover a large range and include those that are not based on existing medications, are made by a different manufacturer, use different inactive ingredients, are used for a different purpose, or undergo any substantial change. Meanwhile, generic drugs are chemical equivalents of name-brand drugs whose patents have expired and require scientific evidence that the generic version of the drug is interchangeable with the originally approved drug. Lastly, OTC drugs such as aspirin are drugs that utilize previously-approved ingredients that do not require a doctor's prescription. The CDER monitors these drugs and the various combinations of ingredients that may be used to treat certain diseases or conditions without a prescription, the appropriate dosage, and instructions for use and labeling.

It is often the case that publicly traded companies experience sizable gains or losses associated with decisions and announcements by the FDA with regard to a company's drug candidate(s). As such, investors and traders alike frequently seek out these companies with upcoming FDA catalysts in an effort to take advantage of these price movements. Some companies with upcoming catalysts – which are discussed in this report – include Avanir Pharmaceuticals (AVNR), EDAP TMS S.A. (EDAP) and XOMA Corporation (XOMA).

Copy and paste to browser may be required.


This report may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward- looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of mentioned company to be materially different from the statements made herein.   


Content is researched, written and reviewed on a best-effort basis. Research report provided for informational purposes. This document, article or report is written and authored by Michael Maggi, Chartered Financial Analyst. However, we are only human and are prone to make mistakes. If you notice any errors or omissions, please notify us below.

A full disclaimer can be found by viewing the full analyst report.

BrokerBank Securities, Inc. is a member of the Financial Industry Regulatory Authority, CRD number #130116.

©2012 PR Newswire. All Rights Reserved.

Powered by WorldNow