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Blood Glucose Monitoring Test Systems Guidance

[ Price : $8.95]

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

Clinical Trial Guide on Covid-19 Symptoms

[ Price : $8.95]

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

Guide on Gaining Final ANDA Approval

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Amendments and Requests for Final Approva...

Meeting on Systemic Sclerosis Patient Perspectives

[ Price : $8.95]

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

FDA Sticking with Vaccine Guidance: Hahn

[ Price : $8.95]

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

Breast Implant Labeling Guidance

[ Price : $8.95]

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

Latest FDA Warning Letters

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

ICH Draft Q&A Guide on DNA Reactive Impurities

[ Price : $8.95]

FDA posts an International Council for Harmonization draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic)...

Guidance on Drug Importation

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Importation of Certain FDA-Approved Human Prescription Drug...

Inovio Covid-19 Vaccine Trial on Partial Hold

[ Price : $8.95]

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