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Human Drugs

Inhousepharmacy Selling Illegal Unapproved Drugs: FDA

FDA warns inhousepharmacy.vu that it is illegally marketing domperidone drug products in the U.S.

Medical Devices

Dont Use Skippack Covid Rapid Test: FDA

FDA says the Skippack Medical Laboratory recall of rapid Covid-19 tests that were not cleared, approved, or authorized is Class 1 and people should no...

Biologics

Committee Documents Emergent Manufacturing Failures

A House committee staff report blasts Emergent Biosolutions for hiding its Covid-19 vaccine manufacturing problems from FDA and HHS.

Human Drugs

Lillys Olumiant Approved for Covid-19

FDA approves a new indication for Eli Lillys Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplemental oxygen, non-in...

Federal Register

Istodax T-cell Lymphoma Indication Withdrawn

Federal Register notice: FDA announces that it is withdrawing approval of Bristol Myers Squibbs (Celgene) peripheral T-cell lymphoma indication for Is...

Federal Register

Drug Compounding Panel Discussing 4 Bulk Drugs

Federal Register notice: FDA announces a 6/8 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances that have been nomin...

Federal Register

Guide on Device Quality Improvement Program

Federal Register notice: FDA makes available a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Vo...

Federal Register

Draft Guide on Testosterone ANDA Bioequivalence

Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Testosterone.

Federal Register

FDA Revokes EUAs on 2 Covid Tests

FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distributed Covid-19 test...

Human Drugs

Guidance on Considerations for Drug Quality Assessments

FDA posts a draft guidance entitled Benefit-Risk Considerations for Product Quality Assessments, which describes the agencys benefit-risk principles u...