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Medical Devices

Breast Implant Labeling Guidance

FDA issues a guidance on the content and format for some labeling information for breast implants.

Federal Register

Blood Glucose Monitoring Test Systems Guidance

Federal Register notice: FDA announces the availability of a final guidance on Blood Glucose Monitoring Test Systems.

Federal Register

Clinical Trial Guide on Covid-19 Symptoms

Federal Register notice: FDA makes available a final guidance on assessing Covid19-related symptoms in clinical trials.

Federal Register

Guide on Gaining Final ANDA Approval

Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Amendments and Requests for Final Approval to Tentatively App...

Human Drugs

Meeting on Systemic Sclerosis Patient Perspectives

FDA announces a 10/13 virtual public meeting on Patient-Focused Drug Development for Systemic Sclerosis to obtain patients perspectives on disease imp...

Biologics

FDA Sticking with Vaccine Guidance: Hahn

Speaking at a Financial Times conference, FDA commissioner Stephen Hahn says the agency will follow guidelines it has given to industry for approving ...

Medical Devices

Breast Implant Labeling Guidance

FDA issues a guidance on the content and format for some labeling information for breast implants.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Intrathecal Compounding Specialist and Panacea Biotec.

Federal Register

Guidance on Drug Importation

Federal Register notice: FDA makes available a final guidance entitled Importation of Certain FDA-Approved Human Prescription Drugs, Including Biologi...

Biologics

Inovio Covid-19 Vaccine Trial on Partial Hold

FDA places a partial clinical hold on an Inovio planned Phase 2/3 trial of its Covid-19 vaccine candidate INO-4800, including its Cellectra 2000 deliv...