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Members Sought for Mammography Quality Panel

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advi...

FDA Extends Review of Tecentriq sBLA

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FDA extends by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Av...

Guide on Dietary Supplement Microbial Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Quantitative Labeling of Dietary Supplemen...

Labeling Changes to 3 HIV Drugs

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FDA approves labeling changes for three ViiV HIV drugs containing dolutegravir to address risk of neural tube defects.

Court Dismisses PhRMA Drug Price Suit

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A California federal court dismisses PhRMAs suit against a state drug pricing transparency law and gives the association an opport...

Surgical Innovation Mesh for Cosmetic Surgery Cleared

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FDA clears a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of advanced bioabsorbable technologies f...

FDA Denies Probiotics CFU Petition

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FDA says it will continue to monitor research into quantifying live microbial dietary ingredients in probiotics rather than approv...

FDA Revises Drug Compounding MOU

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FDA commissioner Scott Gottlieb announces a revised memorandum of understanding to be signed with states that want to collaborate ...

PQ/CMC Meeting Scheduled for 10/19

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FDA sets a 10/19 public meeting on standardized data for electronic submission of Pharmaceutical Quality/Chemistry Manufacturing a...

FDA Enteral Device Connector Concerns

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FDA airs concerns about misconnections with enteral devices.