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
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 10/30/2020.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
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...
