dies on healthy humans and large groups of clinical patients. When enough research is conducted on a drug, a company can file a New Drug Application (NDA) to the FDA for approval review. The third and final stage is the actual process of the FDA's approval for marketing. In the past, the process took an average of 3 years to review a drug, but certain drugs with high potential and demand could receive approval in under a year (Ballance 93). Now, many drugs are being approved in as little as 6 to ten months.Over the last 6 years, the FDA has been making an effort to speed the approval process with new acts and amendments designed to get drugs on the market quicker. Many of the reformations to the approval process pertain to drugs for patients with serious or life-threatening illnesses such as Alzheimer's, cancer and AIDS. While these modifications help many people receive new and experimental drugs that could significantly help their conditions, the FDA claims that they have safeguards ensuring that the approval process isn't compromised. One new procedure, Treatment IND, provides approval when there is no effective alternative treatment. This has allowed many new AIDS drugs into the market. Parallel Track approval makes new drugs for treating HIV-related diseases available to patients who are unable to take standard therapy. With Parallel Track, patients are given the option to agree to take experimental drugs. The FDA can approve a drug on "surrogate endpoints" with Accelerated Approval. Promising lab tests and physical signs of clinical benefit can serve as grounds for approval with this procedure, which has allowed many AIDS drugs to be approved. Safety Testing Harmonization allows the FDA to accept safety testing on animals conducted in Japan and a handful of European Countries. If companies can accept tests from international companies, they eliminate duplicate reviews, cutting time off the approval process. In addit...
