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Strides Pharma FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with three observations from an inspection at Indias Stride Pharma Science.

Fast Track for Primary Sclerosing Cholangitis Drug

[ Price : $8.95]

FDA grants HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with pr...

Proposed Rule on QSR Harmonization Due by 4/19: Maisel

[ Price : $8.95]

CDRH chief medical officer William Maisel reaffirms the agencys intention to modernize its Quality System regulation for medical d...

Obalon PMA Supplement OKd for Obesity Device Inflator

[ Price : $8.95]

FDA approves an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, ...

Endo Extends Stay on Vasopressin Suit Against FDA

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Endo extends the stay on a suit against FDA following an agency commitment to finalize its clinical need determination for vasopre...

16 Observations in Pharm D Solutions FDA-483

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FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.

Neurelis NDA for Epilepsy Nasal Spray

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Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experienc...

Renovid Surgical 3D-printed Interbody Fusion System Cleared

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FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.

Joint Panel to Review Sage Postpartum Depression Drug

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Federal Register notice: FDA announces an 11/2 joint advisory committee meeting to review a Sage Therapeutics NDA for its proposed...

Draft Guide on Good Review Management

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Federal Register notice: FDA makes available a draft guidance entitled Good Review Management Principles and Practices for New Dru...