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Guide on ANDA Complete Response Letters

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter With...

Final guide on Breast Implant Labeling

[ Price : $8.95]

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

Qualitative Data Collection on Tobacco Products

[ Price : $8.95]

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

Cardio/Renal Drugs Panel Charter Extended

[ Price : $8.95]

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

CGMP Violations at Panacea Biotec

[ Price : $8.95]

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

Intrathecal Compounding Specialist Inspection Violations

[ Price : $8.95]

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

Breast Implant Labeling Guidance

[ Price : $8.95]

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

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...