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New Warning on Clozapine and Constipation

[ Price : $8.95]

FDA requires a new warning and updates on clozapine products and related constipation risks, which can progress to serious bowel c...

3 Not Marketed Animal Drugs Withdrawn

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Federal Register notice: FDA withdraws approval of a new animal drug application and two abbreviated new animal drug applications ...

Drug Effectiveness Guide Comment Period Extended

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Federal Register notice: FDA extends until 3/19 the comment period for its draft guidance on Demonstrating Substantial Evidence of...

Guide on Minimal Residual Disease Biomarkers

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Federal Register notice: FDA makes available a final guidance entitled Hematologic Malignancies: Regulatory Considerations for Use...

Proposed DTC Research on Ad Product Endorsements

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FDA seeks comments on two proposed studies entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.

Corium NDA for Transdermal Alzheimers Drug

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FDA accepts for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system) for treating Alzheimers-type dementia.

GT Medical Expanded Use for GammaTile Therapy

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FDA clears a GT Medical Technologies 510(k) for GammaTile Therapy expanded use in surgically targeted radiation therapy in patient...

Dificid Expanded Approval for Pediatric Use

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FDA approves Mercks Dificid (fidaxomicin) oral suspension and tablets for expanded use treating Clostridium difficile infections ...

Draft Guide on Arthroscopy Pump Tubing Sets

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FDA posts a draft guidance on Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Sub...

FDA Web Page on Coronavirus Product Development

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FDA launches a new Web page to help companies advance development of novel coronavirus medical countermeasures.