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FDA Expands Use of Abiomeds Impella CP Heart Pump

[ Price : $8.95]

FDA expands approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions...

Gilead Submits NDA for Triple Drug Combo for Hep C

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Gilead Sciences files an NDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 10...

Cures Act Device Provisions Explained

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Two Hyman, Phelps attorneys outline key medical device provisions in the 21st Century Cures Act that has overwhelmingly passed the...

Former Deputy Commissioner Gottlieb Added to FDA Short List

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President-elect Donald Trumps transition team reportedly adds former FDA deputy commissioner Scott Gottlieb to the short list of c...

BMS Pays $19.5 Million to Settle Abilify Off-label Charges

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Bristol-Myers Squibb enters into a $19.5 million settlement agreement with 43 states to resolve allegations the company used false...

Federal Drug Wholesaler Standards Sought

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Five stakeholders reiterate positions and add new insights from an FDA meeting on progress made toward implementing product identi...

Groups Suggest Changes to Software 510(k) Guidance

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Stakeholders say they appreciate an FDA draft guidance on when medical device software changes require a new 510(k) and offer prop...

Praise for Biosim User Fee Agreement

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Three industry stakeholders praise the agreement reached for reauthorization of the Biosimilars User Fee Act.

FDA Moves to Improve Hearing Aid Accessibility

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FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid, and it is consi...

CFSAN Posting Adverse Event Data Files

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Federal Register Notice: FDA makes available data extracted from adverse event reports from 2004 to the present for food (includin...