Mobi Health News | Q&A: What FDA Layoffs Mean for MedTech Approvals

Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s final guidance for certain generic drug manufacturers requesting post-warning letter meetings under the Generic Drug User Fee Amendments.

Alston & Bird has received significant recognition in the 2025 edition of Chambers USA: America’s Leading Lawyers for Business, with 77 practice rankings and 164 leading lawyer listings.

This Healthy Byte digests the recent HHS RFI that seeks feedback on modernizing the digital health ecosystem. 

Our FDA Team examines the new Executive Order for promoting domestic production of critical medicines and the Food and Drug Administration’s announcement of expanding the use of surprise inspections at foreign manufacturing facilities.

Ben Wolf will present during this virtual program hosted by the Practicing Law Institute (PLI).

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device Team shares best practices for applicants that engage third-party laboratories to generate data for their FDA submissions. 

Ben Wolf is quoted on the Food & Drug Administration workforce cuts’ impact on the medical technology sector.

Join Cathy Burgess for a pre-conference workshop on March 26 as she discusses “Beauty and the Law 101: Introduction to Cosmetics and Personal Care Products Law and Regulations.”

Cathy Burgess will speak on the panel “cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (cGMPs) in the Post Approval Process” at this two-day conference hosted by the American Conference Institute.