FDA data breach startles drugmakers concerned about sensitive data

Hackers have found their way into the FDA's data vaults on investigational drugs, and industry groups are urging the agency to undergo a third-party audit to make sure that doesn't happen again. Last month, the FDA revealed that a Center for Biologics Evaluation and Research system succumbed to hackers in October, Reuters reports, and while there's some dispute about just what information was compromised, PhRMA and BIO have now joined lawmakers in pressuring the agency to better secure what amount to priceless business secrets. Article

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.