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Alert on Left Atrial Appendage Occlusion Devices

[ Price : $8.95]

FDA alerts health care providers on recent information about the potential for differences in procedural outcomes between women an...

CDER Head Talks Quality Management Maturity

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CDER director Patrizia Cavazzoni tells an industry conference that agency inspectors are emphasizing the importance of having in p...

Enforcement Discretion for Certain IVD Studies

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FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device...

Clinical Hold Lifted on Angelman Syndrome Study

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FDA removes a clinical hold against a GeneTx Biotherapeutics and Ultragenyx Pharmaceutical clinical trial of GTX-102, an investiga...

Armstrong Medical Recalls Anesthesia Gas Cans

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Armstrong Medical recalls its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow ...

Sunscreen OTC Monograph Proposed Order Available

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Federal Register notice: FDA makes availability of an over-the-counter monograph proposed order entitled Amending Over-the-Counter...

FDA Revokes 3 EUAs for No-longer-marketed Tests

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Federal Register notice: FDA revokes the emergency use authorizations for three Covid-19 tests after the companies requested such ...

FDA Generic Drugs Office Modifies Scientific Priorities

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The CDER Office of Generic Drugs revises its scientific priorities as part of its user fee performance goals through 2022.

FDA Approves Expanded Repatha Use

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FDA approves an Amgen supplemental BLA for Repatha (evolocumab) injection as an add-on treatment to diet alone or together with ce...

FDA Approves Tivdak for Cervical Cancer

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FDA grants Genmab and Seagen accelerated approval for their BLA for Tivdak (tisotumab vedotin-tftv), an antibody-drug conjugate fo...