FDA says Edge Pharma is illegally marketing its mixtures of allergenic extracts for allergy treatment.
Two professors urge President Biden to appoint former FDA principal deputy commissioner Joshua Sharfstein as the agencys new commissioner.
CDRH issues a 2020 annual report for the Accreditation Scheme for Conformity Assessment (ASCA) pilot program, describing progress to date toward imple...
FDA releases its latest batch of Warning Letters that include Sage Moon Apothecary and Yuyao Yijia Daily Chemical Co.
CDERs Office of Prescription Drug Promotion says its regulatory attention in 2021 will focus on promotional materials involving high-risk drugs, launc...
Federal Register notice: FDA withdraws a 1/21-posted final rule that provided additional information on the content and format of reports intended to ...
Federal Register notice: FDA withdraws a 1/21-posted final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requ...
The Advanced Medical Technology Association tells FDA that early stakeholder engagement is critically important when the agency is considering medical...