Critics of LDT Draft Guidance Call for FDA To Conduct Full Notice-and-Comment Rulemaking

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

By signing up for a tour of the Thompson FDA Compliance Expert Suite, you are also registering to receive email offers and product updates from us. Simply click unsubscribe at the bottom of any email if you would like to discontinue delivery.

Critics of LDT Draft Guidance Call for FDA To Conduct Full Notice-and-Comment Rulemaking

Dennis Tosh

Guide to Medical Device Regulation

November 20, 2014 at 08:58 AM EST

On Nov. 18 a group of stakeholders asked Commissioner of Food and Drugs Dr. Margaret A. Hamburg to withdraw the framework for regulatory oversight of laboratory-developed tests (LDTs) proposed by the FDA Oct. 3. They also called for the FDA to withdraw any guidance released by the agency in connection with the proposed framework, which would include draft guidance on notifica... Read More

My Research Folders

You are not Logged in yet, Please login to see Your research folders.

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

Critics of LDT Draft Guidance Call for FDA To Conduct Full Notice-and-Comment Rulemaking

My Research Folders

THOMPSON FDA

COMPLIANCE EXPERT

RESOURCES

HELP

CONTACT