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Federal Register

Final guide on Breast Implant Labeling

Federal Register notice: FDA makes available a final guidance on Breast Implants Certain Labeling Recommendations to Improve Patient Communication.

Federal Register

Qualitative Data Collection on Tobacco Products

Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qualitative Data on Tob...

Federal Register

Cardio/Renal Drugs Panel Charter Extended

Federal Register notice: FDA announces the renewal of its Cardiovascular and Renal Drugs Advisory Committee for an additional two years.

Human Drugs

CGMP Violations at Panacea Biotec

FDA warns Indias Panacea Biotec about CGMP violations in its production of finished drugs.

Human Drugs

Intrathecal Compounding Specialist Inspection Violations

FDA warns Intrathecal Compounding about deficiencies in its production of sterile drugs.

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...