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Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug o...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

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Human Drugs

Draft Guide on Pulmonary Tuberculosis Drugs

FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.

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Draft Inspection Refusal Guidance

FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspection, or refusing to p...

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Biologics

FDA Stem Cell Therapy Regulation at Risk: Attorneys

Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem cell clinics.

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Human Drugs

FDA Updates CRL Guidance Performance Goals

FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.