FDA Related News

Medical Devices

Import Alert on Hand Sanitizers from Mexico

FDA places all alcohol-based hand sanitizers from Mexico on import alert to intercept them until the agency is able to review their safety.

Medical Devices

CareFusion 303 FDA-483 Released

FDA releases the FDA-483 with eight inspection observations issued to CareFusion 303.

Edge Pharma Illegally Marketing Allergenic Extracts: FDA

FDA says Edge Pharma is illegally marketing its mixtures of allergenic extracts for allergy treatment.

FDA General

Professors Push Sharfstein for FDA Commissioner

Two professors urge President Biden to appoint former FDA principal deputy commissioner Joshua Sharfstein as the agencys new commissioner.

Medical Devices

ASCA Annual Report Issued

CDRH issues a 2020 annual report for the Accreditation Scheme for Conformity Assessment (ASCA) pilot program, describing progress to date toward imple...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Sage Moon Apothecary and Yuyao Yijia Daily Chemical Co.

OPDP Outlines Drug Promotion Priorities

CDERs Office of Prescription Drug Promotion says its regulatory attention in 2021 will focus on promotional materials involving high-risk drugs, launc...

Federal Register

Tobacco Product Substantial Equivalence Rule Withdrawn

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

Rule on Premarket Tobacco Product Apps Withdrawn

Federal Register notice: FDA withdraws a 1/21-posted final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requ...

Medical Devices

AdvaMed Wants Early Engagement on Device Safety Notices

The Advanced Medical Technology Association tells FDA that early stakeholder engagement is critically important when the agency is considering medical...