Online Safety Community

FDA Scrutiny of Promotion and Advertising Practices

Event Details

FDA Scrutiny of Promotion and Advertising Practices

Time: January 17, 2019 at 9am to January 18, 2019 at 6pm
Location: Hilton San Francisco Airport Bayfront
Street: 600 Airport Blvd, Burlingame, CA 94010
City/Town: SFO
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: seminar
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Dec 7

Export to Outlook or iCal (.ics)

Event Description

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.

FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.

In this seminar, you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.

Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work. You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices.

Event link:  https://www.globalcompliancepanel.com/seminar/FDA-scrutiny-of-promotion-and-advertising-practices-901930SEMINAR?safetycommunity-seo

Comment Wall

Comment

RSVP for FDA Scrutiny of Promotion and Advertising Practices to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Nakul Pratap shared their blog post on Twitter
4 hours ago
HrishikeshRam posted blog posts
8 hours ago
Kyle C. Johnson posted a discussion

[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their phones at any time, anywhere. Even the PIT drivers. It's insane. My initial reaction is to say NO HEADPHONES WHATSOEVER, but my ops manager is concerned it will drastically reduce morale. I suggested that each department should have their own radio and they can play music for everyone to hear, at a…See More
20 hours ago
John Robinson posted a blog post

Nutrition Facts labels of pure maple syrup and honey

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.This update to the Nutrition Facts label has incorporated the latest…See More
yesterday

Forum

[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson 20 hours ago.

AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

Tags: elite, crest, technologies, intelligence, Artificial

Started by emmablisa on Monday.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Safety update: OSHA announces fit-test procedures 1 Reply

Fabricators as well as other workers may be required to use respirators to protect themselves from inhaling fumes, particles, or dust when performing cutting, grinding, welding, coating, or painting,…Continue

Tags: online, training, Safety, workplace, PPE

Started by Safety Training International. Last reply by Jen McDade Dec 4.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service