AG/FDA Blog

FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Condu… Read More
Read More

FY 2012 Clinical Investigation Objectionable Activities/Enforcement Trends

Forewarned is forearmed. For FDA-regulated clinical investigations, knowledge of the most common violations cited by the agency upon inspection is a useful tool for examining one’s own procedures and practices. It helps ensure they are not vulnerab… Read More
Read More

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.