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2 Guides Address Product Development and Covid Variants

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FDA issues a new guidance and revises another to assist vaccine, diagnostic and therapeutic product developers to address the emer...

FDA Snubs Brainstorm ALS Therapy Data

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FDA tells BrainStorm Cell Therapeutics that current Phase 3 data will not demonstrate substantial evidence to support a BLA for Nu...

Modifying Vaccines, Tests Due to Variants: Woodcock

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FDA acting commissioner Janet Woodcock announces updated guidance for currently authorized Covid-19 vaccines and diagnostic tests ...

Piccolo Medical SmartPICC System Cleared

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FDA clears a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate...

Stakeholder Participation in Device User Fee Talks

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Federal Register notice: FDA requests notification from public stakeholders of their intent to participate in periodic consultatio...

Covid-19 Guidance Documents Availability

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Federal Register notice: FDA announces the availability of recent guidance documents related to the Covid19 pandemic.

FDA Updates Records for Recent EUAs

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Federal Register notice: FDA updates its records to reflect five recent Emergency Use Authorizations for drug and biological produ...

Pfizer/BioNTech Seek Warmer Vaccine Storage Approval

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Pfizer and BioNTech submit new stability data to FDA to permit their Covid-19 vaccine vials to be stored at warmer temperatures th...

Safety Alert on Pulse Oximeters

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FDA issues a safety alert on the limitations of pulse oximeters.

FDA Clears FX Shoulder 510(k) for Shoulder Prosthesis

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FDA clears an FX Shoulder 510(k) for the Easytech Stemless Anatomic, a shoulder prosthesis featuring primary peripheral fixation.