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House GOPs Demand Clinical Data on Puberty Blockers

[ Price : $8.95]

House Republicans demand the release of clinical data from taxpayer-funded research involving a study of puberty-blocking drugs th...

Info Collection on Antimicrobial Animal Drug Sales

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Sales and Di...

Broader FDA Interpretations Needed for Review Vouchers: Hill

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A bipartisan Congressional effort seeks broader FDA interpretations when awarding priority review vouchers.

FDA Sued Over Drug Compounding Restrictions

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FarmaKeio Outsourcing, a drug compounding outfit, files a lawsuit against FDA seeking a court order to permit the compounding of s...

PharmaTher Complete Response Letter on Ketamine

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FDA sends PharmaTher a complete response letter on its ANDA for Ketarx (ketamine) and its use in anesthesia, sedation, and pain, a...

De Novo Authorization for Dexter Surgical Robot

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FDA grants Distalmotion a de novo marketing authorization for the Dexter Surgical Robot for adult inguinal hernia repair.

Medtronics Affera Mapping/Abalation Device Approved

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FDA approves Medtronics Affera Mapping and Ablation System with Sphere-9 Catheter for treating persistent atrial fibrillation.

Animal Drug Regs Amended to Reflect Approvals

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related...

Kinova Recalls Wheelchair Robotic Arm

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Kinova recalls (Class 1) its Jaco assistive robotic arm to correct the device due to an increased fire hazard.