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Human Drugs

Guide on Drug Wholesaler Return Product Distribution

FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Product Compliance Policy.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 9/20/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 9/20/2019.

Human Drugs

2 Lots of Quinacrine Dihydrochloride API Recalled

Darmerica recalls two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient due to a label mix-up.

Federal Register

Comments Sought on Developing CNS Stimulants

Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous system stimulants.

Federal Register

Device Guidances Under Safety/Performance Pathway

Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency device Safety and Performance Based Pathw...

Medical Devices

Pilot on Device Conformity Assessment Program

FDA releases a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suit...

Human Drugs

Novo Nordisk GLP-1 Approved for Diabetes

FDA approves Novo Nordisks Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 diabetes.

FDA General

Senate Committee OKs $80 mil. FDA Spending Boost

The Senate Appropriations Committee approves an FY 2020 FDA appropriations bill, which includes $3.148 billion in discretionary funding for the agency...

Human Drugs

New Packaging OKd to Reduce Loperamide Abuse

FDA approves package size and package type limits for over-the-counter forms of loperamide, indicated for controlling symptoms of diarrhea.