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Mark S. Brown
Insights 11 results
Client Alert
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
Client Alert
July 1, 2024
Loper Bright v. Raimondo
Feature
December 8, 2023
General Counsel’s Decision Tree for Internal Investigations for the Food and Beverage Industry
Client Alert
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance
Article · Source: WCG CenterWatch
November 1, 2022
Clinical Data Integrity: FDA and DOJ Enforcement Priorities
Client Alert
October 12, 2022
FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News
Client Alert
August 31, 2017
President Trump Signs FDA User Fee Reauthorization Bill into Law – A Relief for the Medical Device Industry
Client Alert
June 10, 2016
FDA Announces New “Compassionate Use” Approval Process for Investigational Drugs
Client Alert
January 26, 2016
FDA Issues New Cybersecurity Guidance for Medical Device Manufacturers
Article · Source: Washington Legal Foundation
March 27, 2015
First Circuit Breathes New Life Into Branded Drug Preemption Defense