RAPS

FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure. While ...
RAPS

FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
JD Supra

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...