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Monitor Compliance Agreements for Enforcement Trends: Posting

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Policy and Medicine urges regulated industry to study new compliance integrity agreements to keep up with enforcement trends.

Analysts See Record Sales for Drugs Approved in 2013

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An EP Vantage report forecasts record post-launch sales for drugs approved this year.

PA Bill Requires Biologic Substitute Notification

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BIO praises a Pennsylvania Senate committee for approving legislation requiring pharmacist notification of biologic product substi...

FDA Approves Another Breakthrough Drug Imbruvica

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FDA approves a second breakthrough-designated drug Pharmacyclics and Janssen Biotechs Imbruvica (ibrutinib) for treating patients...

FDA Proposes Revised Procedures for New Labeling Info

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Federal Register Proposed rule: FDA proposes to revise procedures for approved drug or biological product holders to change labeli...

FDA OKs PresbiBio Phase 2 Trial of Microlens for Presbyopia

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FDA grants conditional approval to PresbiBio LLC for an IDE application to begin a Phase 2 trial of its Presbia Flexivue Microlens...

Depuy Agrees to $4 Billion Settlement on Defective Hip Devices

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Johnson & Johnsons device unit, Depuy, reportedly agrees to pay more than $4 billion to settle thousands of lawsuits over its reca...

FDA Continues Inspecting Hospira as Progress Ticks Along

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Troubled Hospira says it was recently inspected by FDA at its Lake Forest, IL and McPherson, KS facilities.

FDA Asks More Eloctate Manufacturing Process Info

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FDA asks Biogen Idec for additional process validation information for its blood clotting factor Eloctate.

CDRH Draft Guidance on Device Development Tools

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CDRH posts a draft guidance on Medical Device Development Tools that outlines a voluntary process for qualifying medical device de...