Elite Pharmaceuticals Inc (ELTP)

[Couch]

Complete Response Letters1

http://www.healthcarelawinsights.com/wp-content/uploads/sites/667/2015/01/CRL_Whitepaper.pdf

Other applicants merely rely on data from other studies by other investigators to overcome safety deficiencies.

The FDA does not require a drug to be perfectly safe—it requires a drug’s benefits to outweigh its risks. Perceived health risks can be minimized by several strategies according to the data. Framing risk factors and said effects relative to benefits is a powerful tool for applicants to increase chances of approval.

Applicants may demonstrate health risks are smaller than originally believed or change product labeling to warn of potential health risks. Other applicants receive approval after they agree to obtain additional data about the adverse risks of their drugs at a future date, after the drug was sold on the market. Another successful strategy is showing that the drug provides benefits not offered by any other drugs.

Other applicants show that their drug candidate works at lower doses, which may also minimize the occurrence of side effects, or emphasize their drugs exhibit efficacy in patient populations that fail to respond to other commercially available drugs.