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Federal Register

FDA Posts Animal Drug Application Actions

Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions made during January, February, and March.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Eosera and Tender Corp.

FDA General

House Passes FDA Spending Bill with $41 Million Boost

The U.S. House of Representatives passes an FDA spending bill that sets the agencys 2021 discretionary funding at $3.212 billion, an increase of $40.8...

Medical Devices

Guided Therapeutics Study Protocol for Cervical Scan

Guided Therapeutics says it has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Scan.

Biologics

Vaccines Remarkably Safe Over Last 20 Years

Israeli researchers say FDA has a robust vaccine approval and postmarketing surveillance system that worked well over the 20 years they studied.

Human Drugs

Woodcock and Colleagues Defend Integrated Reviews

CDER director Janet Woodcock defends the Centers use of integrated reviews from criticisms that they wont meet agency goals and may introduce new prob...

Federal Register

FDA Orders 10-year Debarment of Park

Federal Register notice: FDA issues a 10-year debarment order against Jin Su Park for importing misbranded drugs into the U.S.

Federal Register

Laing Permanently Debarred by FDA

Federal Register notice: FDA permanently debars Euton M. Laing from providing services in any capacity to a person that has an approved or pending dru...

Federal Register

Seil Debarred for 10 Years by FDA

Federal Register notice: FDA issues a 10-year debarment order against John Seil from importing or offering for import any drug into the U.S.

Biologics

Moderna Begins Dosing in Phase 3 Covid Vaccine Trial

Moderna says it has begun dosing participants in its Phase 3 study of its mRNA vaccine candidate for Covid-19.