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Human Drugs

Appeals Court Rules Against Homeopathic Drug Marketer

The DC Circuit Court of Appeals affirms a lower court decision recognizing FDAs authority to place homeopathic drugs on its import alert listing after...

FDA General

FDA Budget Request Seeks $477 mil. Funding Boost

FDAs fiscal year 2022 budget request seeks an 8% ($477 million) boost for agency activities.

Federal Register

FDA Reinstates Unapproved Drugs Initiative

Federal Register notice: FDA withdraws a notice by the previous administration that would have ended the agencys unapproved drugs initiative.

Federal Register

Guide on Device Post-approval Studies

Federal Register notice: FDA makes available a draft guidance entitled Procedures for Handling Post-Approval Studies Imposed by Premarket Approval App...

Federal Register

Device Postmarket Surveillance Draft Guide

Federal Register notice: FDA makes available a draft guidance entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmet...

Human Drugs

Foresee Pharma NDA Approved for Prostate Cancer

FDA approves a Foresee Pharmaceuticals NDA for Camcevi (leuprolide mesylate) 42 mg for treating advanced prostate cancer.

Human Drugs

FTC Wants AbbVie AndroGel Appeal Denied

The Federal Trade Commission asks the Supreme Court not to hear AbbVies appeal of lower court decisions holding that it engaged in sham litigation to ...

Human Drugs

Probation for Unapproved Drug Distribution Conspiracy

The Justice Department says a Georgia man has been sentenced to five years probation for conspiracy to distribute unapproved drugs and unlawful smuggl...

Human Drugs

EUA for Vir/GSK Covid Antibody Treatment

FDA grants an EUA for Sotrovimab, a monoclonal antibody treatment for Covid-19 developed by Vir Biotechnology and GlaxoSmithKline.

Human Drugs

Justice Department Hits Eli Lilly with Subpoena

U.S. Department of Justice issues a subpoena to Eli Lilly requesting documents about its troubled manufacturing site in Branchburg, NJ.