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Guide on Cold-stored Platelets for Bleeding

[ Price : $8.95]

FDA posts a final guidance entitled Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment...

Guide on OTC Monograph Dispute Resolution

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Formal Dispute Resolution and Administrative Hearings of Final Adm...

Jazz Pharma Sues FDA Over Competitor Approval

[ Price : $8.95]

Jazz Pharmaceuticals sues FDA and seeks the reversal of a 5/1 approval of Avadel CNS Pharmaceuticals Lumryz, a sodium oxybate drug...

New Pathway for Breakthrough Device Coverage

[ Price : $8.95]

Centers for Medicare & Medicaid Services (CMS) issues a proposed procedural notice outlining a new Medicare coverage pathway for b...

OTC Drug Dispute Resolution Guidance

[ Price : $8.95]

FDA publishes a draft guidance on the formal dispute resolution and administrative hearing process for over-the-counter monograph ...

Medical Imaging Drugs Panel Renewal

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Federal Register notice: FDA announces the renewal of the Medical Imaging Drugs Advisory Committee for an additional two years bey...

Arrow Recalls Peripheral Catheter System

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Arrow International recalls its Arrow Endurance Extended Dwell Peripheral Catheter System due to the potential for catheter separa...

Indian Drug Companies Sharing Compliance Info

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A Bloomberg newsletter covering India reports that Indian drug firms are sharing FDA inspection reports and their responses in an ...

FDA Accelerated Approval for Duchenne Gene Therapy

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FDA grants Sarepta Therapeutics an accelerated approval for its BLA for Elevidys, the first gene therapy for treating pediatric pa...

FDA Posts 483 of PQ Drug Outsourcing Facility

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A 10/2022 inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL leads to a just-posted seven-item Form FDA-483 th...