Newsletter - September 28, 2023
FDA Clarifies Meeting Types and Other Details in a New Guidance on Meetings
Meeting the FDA is unquestionably the most important resource available to sponsors/developers of new drugs and biologics. Over the last 30 years, these meetings have evolved into complex procedures. Their potential outcomes depend not on just what you ask but how you ask and when you ask the FDA...Read More
FDA’s Cybersecurity Requirements for Medical Devices
Cybersecurity requirements for FDA-regulated devices are evolving rapidly to stay in step with technological developments. This week the FDA released a detailed guidance document addressing several security issues around medical devices connected to the internet currently in development...Read More
FDA Clarifies Meeting Types and Other Details in a New Guidance on Meetings
Meeting the FDA is unquestionably the most important resource available to sponsors/developers of new drugs and biologics. Over the last 30 years, these meetings have evolved into complex procedures. Their potential outcomes depend not on just what you ask but how you ask and when you ask the FDA...Read More
FDA’s Cybersecurity Requirements for Medical Devices
Cybersecurity requirements for FDA-regulated devices are evolving rapidly to stay in step with technological developments. This week the FDA released a detailed guidance document addressing several security issues around medical devices connected to the internet currently in development...Read More
