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Medical Devices

FDA Caution on Covid Antigen Test False Positives

FDA reminds laboratories and healthcare providers that false positives can occur with antigen tests being used for the rapid detection of SARS-CoV-2.

Human Drugs

FDA OKs Endari Updated Prescribing Info

FDA approves updated prescribing information for Emmaus Life Sciences Endari (L-glutamine oral powder) to better inform healthcare professionals and s...

FDA General

Consider Making FDA Independent: Law School Professor

Law professor Dorit Reiss outlines ways Congress could restructure FDA to make it better able to withstand political pressure on product approvals.

Federal Register

FDA Service Delivery Feedback Info Collection Extension

Federal Register notice: FDA sends to OMB an information collection extension for Generic Clearance for the Collection of Qualitative Feedback on Agen...

Federal Register

Info Extension on Strategic Stockpile Labeling

Federal Register notice: FDA sends to OMB an information collection extension for Exceptions or Alternatives to Labeling Requirements for Products Hel...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Cosmax USA and Immusist LLC.

Human Drugs

Salix Gets Orphan Status for Sickle Cell Drug

FDA grants Salix Pharmaceuticals an orphan drug designation for rifaximin and its use in treating sickle cell disease.

Human Drugs

White House Intervened in Hydroxy Distribution in April: WaPo

A Washington Post report finds that the White House ordered the National Strategic Stockpile to distribute 23 million hydroxychloroquine tablets from ...

Human Drugs

Lilly Hit on Quality, Lab Controls in New FDA-483

A just-posted Form FDA-483 cites significant quality and laboratory control issues at Eli Lillys Imclone Covid drug manufacturing facility in Branchbu...

Human Drugs

PDUFA Post-market Group Focuses on REMS Assessments

An FDA/industry Prescription Drug User Fee Act reauthorization subgroup discussed the agencys plans on risk evaluation and mitigation strategies asses...