ARTICLE | Clinical News
The Washington Legal Foundation regulatory update
January 2, 1996 8:00 AM UTC
WLF filed a formal Citizen Petition with the FDA and the Securities and Exchange Commission urging the FDA to exempt from its regulation the public disclosure of results of clinical trials. The petition seeks to find a common ground from which companies can report on early stage drug developments while avoiding potential FDA sanctions.
Currently the SEC requires drug companies to file reports to inform the investment community of drug developments, WLF said, while the FDA prohibits drug companies from "promoting" or "commercializing" an IND until the drug is approved by the agency. ...