Drugs, generic approvals, process

Figure 8.6 Approval process for generics. (Source Center for Drug Evaluation and Research. Generic drug (ANDA) approval process, in The CDER Handbook, FDA, Rockville, MD, 2007. http //www.fda.gov/cder/handbook/anda.htm [accessed July 20, 2007].)...

Even this step did not have a profound effect, because the ANDA mechanism was only available to generic copies of drugs first approved before 1962. But in 1984, as part of the compromise to obtain restoration of patent life that was being lost during the drug development and review process, the pharma industry agreed to extension of the ANDA requirement to copies... 

The ffatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act, makes it easier for generic drugs to get approval from the FDA but also allows drug companies to extend their patents when the FDA approval process delays the sales of patented drugs. 

Henry Waxman, Democratic representative from California since 1975. In an unusual instance of cooperation across parties, Waxman cosponsored a bill in 1984 with conservative Republican senator Orrin Hatch called the Drug Price Competition and Patent Restoration Act. The bill helped consumers by making it easier and faster for less expensive generic drugs to get approval from the FDA. It helped drug companies by allowing their patents to be extended when the development and approval process took a particularly long time. 

Welage LS, Kirking DM, Ascione FJ, Gaither CA Understanding the scientific issues embedded in the generic drug approval process. J Am Pharm Assoc (Wash DC). 2001 41 856-867. 

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... 

The Abbreviated New Drug Application (ANDA) process is a shortened process for those drug products that are me too drugs or generic drugs. Once the patent on an approved drug product expires, generic manufacturers may submit applications for... 

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