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Many Advertised Drugs Have Low Therapeutic Value: Study

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Medical school researchers say most DTC ads are for drugs that do not represent an advance over existing treatments.

Objectionable Conditions in Larkin Hospital IRB

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FDA warns the South Miami, FL-based Larkin Community Hospital institutional review board about failing to adhere to statutory and ...

Fabre-Kramer Resubmits Depression Drug NDA

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After three failed submissions, FDA accepts for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) ex...

Regulatory Review Period Determined for Byfavo

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Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Acacia Pharmas Byfavo ...

Corrective Recall Asked for Hemodialysis Units

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The Service Employees International Union United Healthcare Workers West asks FDA to order five changes to certain Fresenius USA ...

2022 FDA Advertising, Promotion Enforcement Reviewed

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Five King & Spalding attorneys review the nine advertising and promotion enforcement letters FDA issued in 2022.

Tidepool Loop Insulin Dosing App Cleared

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FDA clears a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patie...

FDA Backs Status Quo in Orphan Drug Exclusivity

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An FDA clarifying notice says the agency will continue to make orphan drug exclusivity decisions based on a drugs specific approve...

FDA Moving to Annual Covid Strain Selection Like Flu

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FDA plans to discuss 1/26 a new strategy to annually select Covid-19 strains in June for immunizations beginning no later than Sep...

FDA Releases Cannabis Clinical Research Guidance

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FDA issues its long-awaited final guidance entitled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical R...