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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...

Medical Devices

Federal Court Hits Clinic Owner on Device Adulteration

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

Biologics

Regeneron Interrupts Covid-19 Trial Enrollment

Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in REGN-COV2 antibody ...

Human Drugs

Guide on Drug Standardized Study Date eSubmissions

FDA posts a revised guidance on Providing Regulatory Submissions in Electronic Format Standardized Study Data.