Manufacturers, Pharmaceutical Industry, Adverse Events

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

American Conference Institute (ACI) on 1/5/2021

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under...

Arnall Golden Gregory LLP on 10/2/2020

AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on 9/11/2020

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

Troutman Pepper on 11/9/2017

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

Searcy Denney Scarola Barnhart & Shipley on 4/19/2016

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Manufacturers › Pharmaceutical Industry › Adverse Events

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under...

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

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