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Medical Devices

Advanced Bionics Paying $12 Million Over False Claims

Advanced Bionics agrees to pay more than $12 million to the federal government and participating Medicaid states to resolve a whistleblowers suit alle...

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Human Drugs

Cytalux Approved for Lung Cancer Lesion Detection

FDA approves an On Target Laboratories supplemental NDA for Cytalux (pafolacianine) to help surgeons in identifying lung cancer lesions.

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Biologics

FDA OKs Ferrings Bladder Cancer Gene Therapy

FDA approves a Ferring Pharmaceuticals BLA for Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector‑based gene thera...

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Biologics

Panel to Examine Ongoing Covid Vaccine Modifications

FDA says it is holding a 1/26/2023 meeting of its Vaccines and Related Biological Products Advisory Committee to consider whether current Covid-19 vac...

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FDA General

Contractor Conflict-of Interest Bill Passes Congress

Congress passes S 3905 Preventing Organizational Conflicts of Interest in Federal Acquisition Act that aims to curb government contractors from having...

Federal Register

Notice Correction on CDISC Study Data Tabulation

Federal Register notice: FDA corrects an 8/20 notice to reflect the correct dates that the support and requirement were to begin for version 1.7 of th...

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Federal Register

Guide on What Constitutes an Inspection Delay/Refusal

Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug o...

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Animal Drugs

Updated CVM Guide on Antimicrobial Resistance Risks

FDA issues a draft update to guidance for industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological ...

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Medical Devices

Providence Medical Tech Cavux Facet Device Cleared

FDA clears a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for an anterior pseudart...

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Human Drugs

Aurigene Ditches Psoriasis Drug Candidate

Dr. Reddys subsidiary Aurigene Oncology halts the development of its psoriasis investigational drug after reporting poor results of a placebo-controll...