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Multiple Violations in Lengthy Biomic Inspection

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FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary su...

Spinearts Scarlet Anterior Cervical Cage Cleared

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FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.

Teva Spurns FDAs Beta-Lactam Drug Recommendation

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Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-cont...

ICH Pharmacoepidemiological Study Guidance Out

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FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, ...

Sanofi Sarclisa sBLA Accepted for Priority Review

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FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treat...

Workshop on Patient-Generated Health Data

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FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.

Platform Technology Designation Guidance

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FDA publishes a draft guidance on the drug development platform technology designation program.

FDA Seeks to Withdraw 4 NDAs

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Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file r...

Pfizer Wins Priority Review Voucher for Paxlovid

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Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the crite...

Lawmakers Want FDA Jurisdiction on Execution Drugs

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Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 201...