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Apotex India-made Ingredient Costs Biohaven NDA Approval

[ Price : $8.95]

Citing issues with the drugs Apotex India-made research active ingredient, FDA issues Biohaven Pharmaceutical Holding Co. a comple...

BD Recalls Alaris Pump Bezel Assembly

[ Price : $8.95]

Becton Dickinson recalls its Alaris Pump Module Model 8100 bezel assembly because of a defect that could result in inaccurate flui...

Vanda sNDA Deficiencies Preclude Certain Reviews: FDA

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Vanda Pharmaceuticals receives FDA notification about undisclosed sNDA deficiencies with a supplemental NDA for Hetlioz (tasimelte...

Study Finds 1st Digital Med was Approved on Weak Data

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A new study in BMJ criticizes the strength of the data on which FDA based its 2017 approval of Otsuka Pharmaceuticals NDA for ment...

Final Guide on Combo Product Safety Reporting

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FDA posts a final guidance on Postmarketing Safety Reporting for Combination Products.

Accredited Persons Inspection Program Info Collection

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Federal Register notice: FDA sends to OMB an information collection extension for its device accredited persons inspection program...

FDA Adopts Geopolitical Naming/Coding Standard

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Federal Register notice: FDA announces that it will adopt the current version of the Geopolitical Entities, Names, and Codes (GENC...

FDA to Study Physician Perceptions in Drug Marketing

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CDERs Office of Prescription Drug Promotion (OPDP) proposes research to determine how physician perceptions are influenced by drug...

Celgenes Otezla Approved for Oral Ulcers

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FDA approves a Celgene NDA for Otezla (apremilast) 30 mg twice daily for treating adult patients with oral ulcers associated with ...

Guide on Next-Gen Sequencing Data for Antivirals

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FDA releases a final guidance on submitting next generation sequencing data to the Division of Antiviral Products.