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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...

Human Drugs

FDA Signs MOU on Stopping Products at Mail Facilities

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

Medical Devices

Boston Scientific Ranger Balloon OKd for PAD

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

Human Drugs

Janssen sNDA for 6-month Schizophrenia Dosing

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

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 10/30/2020.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/30/2020.

Federal Register

FDA Withdraws 11 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of 11 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...