JD Supra

EPA Proposes Rule To Formalize Guidance Document Process

On May 19, 2020, the Environmental Protection Agency (“EPA”) released a proposed rulemaking that would codify the EPA’s practice under the Trump administration’s Executive Order 13891 “Promoting the ...
JD Supra

FDA issues draft guidance on providing regulatory submissions in electronic format

On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published adraft guidance document entitled "Providing Regulatory Submissions for Medical Devices in Electronic Format – ...
FiercePharma

FDA finalizes guidance on promotional materials for biologics and biosimilars

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
PharmTech

Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's ...