FDA Guidance Provides Clarity to Drug and Medical Device Companies
THIS IS MEMBERS-ONLY CONTENT
You are not logged in and do not have access to members-only content.
If you are already a registered user or a member, SIGN IN now.
Related articles
-
Article
Drug, Device Companies Face New FDA Electronic Submissions
The Food and Drug Administration is overhauling how it accepts submissions for a host of filing requirements imposed on drug and medical device makers. For many, this will be the first time the submissions have ever been filed electronically. While the move away from paper documents may ultimately be advantageous ...
-
ArticleDecision time for compliance as U.K. CCI regime ditches formulaic reporting to engage investors
A new U.K. Consumer Composite Investments regime comes into force on April 6 and will apply to all firms that manufacture or distribute CCI products to retail investors in the U.K. This includes some firms that are not regulated by the Financial Conduct Authority.
-
News BriefEY compliance partner leaves after independence failings prompt regulatory investigation
Four senior partners at Big Four accountancy firm Ernst & Young, including a leader in the firm’s compliance function, have left the company because of spiralling repercussions from a costly compliance failure.