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Drug Prices Set on What Market Will Bear: Study

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Harvard Medical School researchers say that high U.S. drug prices are caused primarily by FDA-awarded market exclusivity and paten...

Court Rejects Homeopathic Labeling Suit Settlement

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A California federal court cites recommendations from seven attorneys general in rejecting a proposed settlement in a homeopathic ...

FDA Clears Amedica Expanded Valeo II Lateral Lumbar

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FDA clears an Amedica 510(k) for expanded Valeo II Lateral Lumbar sizes.

Drug, Device Recalls Up in 2nd Quarter

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The Stericycle Recall Index shows that drug and medical device recalls were up in the second quarter of 2016 over first quarter to...

Patients Can Reduce Contact Lens Risk: CDC

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A CDC report calls for promotion activities to inform contact lens wearers of modifiable behaviors that can lead to corneal infect...

BioMerieux Offers UDI Guidance Clarifications

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bioMerieux recommends four changes to an FDA draft guidance on the form and content of unique device identifiers.

Companies Recalling More Kogenate/Helixate FS Lots

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FDA says Bayer has added eight more lots to the two lots of Kogenate FS being recalled due to potency declining faster than expect...

Guidance on Device Patient Preference Info

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Federal Register Notice: FDA releases a guidance on patient preference information for devices, which may inform FDAs benefit-risk...

Guidance on Fidaxomicin Bioequivalence Studies

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Federal Register Notice: FDA releases a draft guidance providing recommendations on the design of bioequivalence studies to suppor...

FDA Proposes to Expand Animal Drug Investigator Ineligibility

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Federal Register Proposed rule: FDA proposes to amend the regulations for new animal drugs for investigational use to expand the s...