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Comments Extended on Animal Drug Labeling Rule

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Federal Register notice: FDA extends the comment period on its proposed rule entitled Labeling Requirements for Approved or Condit...

Otsuka Scraps Alzheimers Agitation Drug

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Based on disappointing Phase 3 trial data, Otsuka Pharmaceutical terminates its development of the novel compound AVP-786 as a pot...

Panel Views Asked on Shield Colorectal Cancer Screen

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FDA asks an advisory panel to vote on the safety and effectiveness of the Guardant Shield colorectal screening test for use with p...

CDRH Seeks Non-voting Industry Panel Reps

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Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting in...

AdvaMed Ideas to Help ASCA Achieve its Promise

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AdvaMed makes five suggestions to help FDA improve revised Accreditation Scheme for Conformity Assessment guidances.

Hypoglycemia Risk in Novos Weekly Insulin: FDA

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FDA medical reviewers share with the Endocrinologic and Metabolic Drugs Advisory Committee their concerns about an increased risk ...

Harpreet Singh Leaves FDA for Precision Medicine

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FDA Oncology Drugs Division director Harpreet Singh leaves the agency to join Precision for Medicine as chief medical officer.

Public Citizen Sues FDA to Force SSRIs Decision

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Public Citizen sues FDA to force it to act on a six-year-old petition seeking labeling changes for SSRIs and SNRIs to highlight th...

Hologic BioZorb Marker Recall is Class 1

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FDA says the Hologic recall (correction) of BioZorb markers is Class 1.

Magellan Pays $40 Million Over Faulty Devices

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Magellan Diagnostics (Billerica, MA) agrees to pay $40 million to resolve criminal charges relating to its concealment of a device...