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Roche Files De Novo App for Fertility Assay

[ Price : $8.95]

Roche files a medical device direct de novo application seeking marketing clearance for its fully automated Anti-Mullerian assay f...

FDA Needs Comprehensive IT Plan: GAO

[ Price : $8.95]

The Government Accountability Office says that FDA agrees with its recommendation that the agency define schedules and milestones ...

Dont Work on Only 510(k) Content: Consultant

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Consultant Jon Speer cautions medical device companies not to ignore quality management, design control, and risk management when ...

Stakeholders Praise, Challenge FDA Patient Engagement Ideas

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Stakeholders praise and criticize FDA for its approach to creating a CDRH patient engagement advisory committee.

Fraud Recovery Amount Down This Year: Attorney

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Attorney Alison Nadel says the federal government says that its recoveries from False Claims Act cases have exceeded $3.5 billion ...

Qualitest Settles Whistleblower Suit for $39 Million

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Qualitest Pharmaceuticals agrees to pay $39 million to the federal and several state governments to resolve civil fraud claims ari...

Appeals Court Says Motrin Case Should Have Proceeded

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An Oregon appeals court says the states suit against Johnson & Johnson over its silent recall of defective Motrin should have gone...

Info on Clinical Trial Oversight Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on the oversight of clinical investigation...

Meeting on Biotechnology-Derived Drugs

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Federal Register Notice: CDER and the International Separation Science Society will sponsor a meeting 1/26/16 to discuss the devel...

New HHS Report on Generic Drug Rebates

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A new HHS Office of Inspector General report has found that generic drug price increases exceeded the specified statutory inflatio...