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Latest FDA Warning Letters

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

Salix Gets Orphan Status for Sickle Cell Drug

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

White House Intervened in Hydroxy Distribution in April: WaPo

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

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

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

PDUFA Post-market Group Focuses on REMS Assessments

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

FDA Signs MOU on Stopping Products at Mail Facilities

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FDA commissioner Stephen Hahn says that the agency, the U.S. Customs and Border Protection and the U.S. Immigration and Customs En...

Boston Scientific Ranger Balloon OKd for PAD

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FDA approves Boston Scientifics Ranger Drug-Coated Balloon for treating patients with peripheral artery disease in the superficial...

Janssen sNDA for 6-month Schizophrenia Dosing

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Janssen Pharmaceutical files a supplemental NDA for paliperidone palmitate 6-month (PP6M) for treating adults diagnosed with schiz...

FDA Withdraws 11 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 11 ANDAs from multiple applicants after they notified the agency that the drug ...

Federal Court Hits Clinic Owner on Device Adulteration

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The Western Michigan District Court sentences Roger D. Beyer to 57 months in federal prison for his involvement in a conspiracy to...