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Federal Register

Model Drug Facts Label for Non-Rx Naloxone

Federal Register notice: FDA makes available a model Drug Facts label for nonprescription naloxone, indicated for treating opioid overdose.

Human Drugs

Trump Admin Proposes $419 Million Budget Boost for FDA

The Trump Administration proposes a 7% boost ($419 million) in FDAs 2020 budget, which includes more than $220 million to continue advancing new initi...

Human Drugs

CytoDyn Seeks Fast Track for Leronlimab in Breast Cancer

CytoDyn seeks fast track status for leronlimab (PRO 140) after it showed a significant reduction in the volume of human breast cancer tumor metastasis...

Medical Devices

Breakthrough Status for Alcyone Lifesciences ThecaFlex DRx

FDA grants Alcyone Lifesciences a breakthrough device designation for its ThecaFlex DRx System, an implantable subcutaneous port and intrathecal cathe...

Human Drugs

FDA Expands Use of Regenerons Dupixent for Dermatitis

FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis wh...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 2/8/2019.

Federal Register

Comments Sought on Info Collection for CDRH Appeals

Federal Register notice: FDA seeks comments on an information collection extension for Center for Devices and Radiological Health Appeals Processes.

Federal Register

New Info Collection on Bio Product Name Suffix

Federal Register notice: FDA seeks comments on a new information collection for Proposed Suffix for the Proper Name of a Biological Product.

Federal Register

Draft Guide on Biologic Product Nonproprietary Naming

Federal Register notice: FDA makes available a draft guidance entitled Nonproprietary Naming of Biological Products: Update.

Marketing

FDA Plans Survey on Drug Promotion Targeted at Physicians

FDA seeks comments on a new information collection related to a proposed Healthcare Professional Survey of Professional Prescription Drug Promotion.