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Medical Devices

Acutus Expands Left-Heart Access Devices

FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and...

Federal Register

Guide on Oligonucleotide Drug Development

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...

Medical Devices

Nasal Spray Film Cleared for Allergic Rhinitis

FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.

Federal Register

Info Collection on Pilot Survey for Health Projects

Federal Register notice: FDA sends to OMB an information collection entitled Pilot Survey to Develop Standardized Reporting Forms for Federally Funded...

Human Drugs

OTC Drug Proposal to Offer New Class of Products

FDA proposes to expand options for drug companies seeking to market a nonprescription drug product to allow an additional condition for potential nonp...

Federal Register

AbbVie Redeemed Priority Voucher for Rinvoq sNDA

Federal Register notice: FDA announces that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemental NDA for Rinvoq (...

Human Drugs

Nuvation Bio Phase 1 Trial Hit with Clinical Hold

FDA places a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors after receiving reports of an eye inflam...


Vaccines Panel Mulls Omicron Boosters

FDAs Vaccines and Related Biological Products Advisory Committee meets to discuss whether and how the SARS-CoV-2 strain composition of Covid-19 vaccin...

Human Drugs

Innovative Trial Design Work Highlighted in CDER Report

A new CDER Office of New Drugs annual report highlights some of its work with sponsors to advance innovative clinical trial designs.

Human Drugs

Hold Placed on Astellas Gene Therapy

FDA issues a clinical hold on Astellas Pharmas FORTIS Phase 1/2 gene therapy trial following a report of peripheral sensory neuropathy in one of the t...