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Medical Devices

FDA Clears VySpan System

FDA clears the VySpine VySpan posterior cervical thoracic system.

Federal Register

Organization Structures at 4 FDA Centers Modified

Federal Register notice: FDA announces that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational structures.

Medical Devices

FDA Clears Meridian Campylobacter Assay

FDA clears a Meridian Bioscience 510(k) for the Curian Campy assay, a rapid, qualitative fluorescent immunoassay for detecting Campylobacter-specific ...

Marketing

Revised PhRMA Code Now in Effect

Attorney Faraz Siddiqui explains provisions of the revised PhRMA Code on company interactions with healthcare practitioners and why companies may want...

Human Drugs

FDA Lifts Hold on Spero Antibacterial Trial

FDA removes a Spero Therapeutics clinical hold on a Phase 2 trial of SPR720, an investigational oral product being developed for nontuberculous mycoba...

FDA General

FDA Postpones Inspections as Omicron Spreads

FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for mission-critical inspections because of safet...

Human Drugs

Ideal Pharmacy Inspection Observations

FDA releases an FDA-483 with seven observations from an inspection at Union, NJ-based Ideal Pharmacy.

Federal Register

FDA Chief Scientist Office Organization Structure Modified

Federal Register notice: FDA announces that its Office of the Chief Scientist has modified its organizational structure.

Human Drugs

Allowable Excess Volume/Content MAPP

The CDER Office of Pharmaceutical Quality issues a MAPP for its product quality assessors on consistent assessment of excess volumes in injectable dru...

FDA General

Politics Shouldnt Block Califf: Column

Columbia University College of Physicians and Surgeons psychiatry chair Jeffrey Lieberman makes the case for Robert Califf to return to FDA as commiss...