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BIMO Inspection e-Submission Requirements Outlined

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An FDA Webinar discusses drug study information in NDAs/BLAs that will need to be electronically submitted in a certain format to ...

RM Pharma Gains Low-Dose HemiClor Approval

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FDA approves an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults.

Clinical Trials for Covid Boosters: Makary

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FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.

Teleflex Gains Expanded Use on QuikClot Device

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FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of inter...

Amicis Research Didnt Follow Investigation Plan: FDA

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FDA warns Dr. Nana Barseghian about a bioresearch monitoring violation in a clinical trial at Northridge, CA-based Amicis Research...

Trump Administration Seeks Mifepristone Case Dismissal

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The Trump administration asks a federal judge to dismiss a lawsuit filed by three GOP states that seeks to block access to the abo...

Eye Disease Gene Therapy Misses Endpoint: J&J

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Johnson & Johnson says its gene therapy botaretigene sparoparvovec missed the primary endpoint in the Phase 3 LUMEOS study that is...

Drug Spending Accelerated Last Year: Report

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A new report from IQVIA finds drug spending in 2024 accelerated, with net prices growing at an 11.4% rate last year compared with ...

Experts Dismiss FDA Drug Development Tools Program

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Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs....

Lab Test Ruling Could Apply to AI at FDA: Researchers

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Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court...