Drug Makers Regularly Hide Reasons Their Drugs are Rejected: Study
Monday, June 15, 2015
Source: THE WALL STREET JOURNAL
Whenever the FDA declines to approve a new drug, the agency issues what is known as a complete response letter to the drug maker detailing the reasons for rejection. But a new analysis of these letters finds a disturbing trend – in recent years, companies often failed to disclose some or all of the information about FDA decisions in press releases and regulatory filings.