PhRMA TO FDA: SCRAP PART 11, RELY ON LEGISLATION FOR eRECORDS POLICY

Drug Industry Daily
KEYWORDS FDA / Part 11 / PhRMA
A A

The FDA should abbreviate or even withdraw 21 CFR Part 11 and instead rely on legislative measures passed by Congress to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency, according to a drug industry trade group.

To View This Article:

Login

Subscribe To Drug Industry Daily