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Medical Devices

Spinearts Scarlet Anterior Cervical Cage Cleared

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

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Human Drugs

Teva Spurns FDAs Beta-Lactam Drug Recommendation

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

Human Drugs

ICH Pharmacoepidemiological Study Guidance Out

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

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Biologics

Sanofi Sarclisa sBLA Accepted for Priority Review

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

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Medical Devices

Workshop on Patient-Generated Health Data

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

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Human Drugs

Platform Technology Designation Guidance

FDA publishes a draft guidance on the drug development platform technology designation program.

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Federal Register

FDA Seeks to Withdraw 4 NDAs

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

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Federal Register

Pfizer Wins Priority Review Voucher for Paxlovid

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

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Human Drugs

Lawmakers Want FDA Jurisdiction on Execution Drugs

Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 2019 opinion blocking F...

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Federal Register

Palacio Debarred Over FDA False Statements

Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...