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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...

Questions, Answers on 2 ICH Guidances

[ Price : $8.95]

FDA issues a draft guidance with questions and answers for two International Council for Harmonization guidances.

Center for Research on Complex Generics Grant

[ Price : $8.95]

FDA awards a $5 million grant to two universities to create a Center for Research on Complex Generics.

Study Questions REMS Effectiveness in Opioid Crisis

[ Price : $8.95]

The HHS Inspector General says REMS are not well suited to quickly address the opioid crisis and makes four recommendations to imp...

FDA Should Up Transparency to Gain Public Trust: Column

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Former FDA principal deputy commissioner Joshua Sharfstein and two co-authors suggest four ways FDA could recommit to greater tran...

Qualitative Data Collection on Tobacco Products

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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

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

CGMP Violations at Panacea Biotec

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

Intrathecal Compounding Specialist Inspection Violations

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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.