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Leverage FDA Alternative Tools Flexibility: Attorneys

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Three Sidley attorneys suggest ways drug companies can take advantage of the flexibility in FDAs guidance on using alternative too...

Alert on Abbotts TactiFlex Ablation Catheter

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FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing ...

6 Observations in Fagron Outsourcing Inspection

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FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.

FDA Approves 2 Biocon Denosumab Biosimilars

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FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.

Safety Labeling Changes Guidance

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FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes a...

Committee Advances Pediatric Voucher Reauthorization

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The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Revie...

sGERD Drug Development Guidance

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FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux d...

J&J Reports Positive Data in Psoriasis Drug

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Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis dr...

Exactech Pays $8 Million in Whistleblower Cases

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The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whistleblowers allegations that th...

Are FDA Advisory Committees Doomed?

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FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of ad...