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In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who require systemic treatment, Fabhalta an oral monotherapy for the treatment of PNH and a priority review voucher award for Genzyme. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
In this edition of Quick Notes, we look at expanded clearance for a smart watch, a retinal camera with designs on uncovering health problems, new software to better track neurological disease and a way to increase radiologists’ efficiency by enabling remote review of MRI scans. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
Over the past week, the FDA issued proposed rules to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals and to require premarket approval applications for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
In this edition of Quick Notes, we review recent FDA drug approvals of combination drug Truqap/Faslodex for breast cancer, DefenCath for hemodialysis patients, non-small cell lung cancer treatment Augtyro, a 38th approval for Keytruda, and an approval for Xtandi for prostate cancer. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes highlights a permanent injunction against a manufacturer of dietary supplements, request for improved post-market evidence standards, a study on lessening cyber threats to legacy devices, drug distribution partners going all-electronic and seeking input on pulse oximeter discrepancies. Read More
Over the past week, the FDA issued final guidance on assessing credibility of computational modeling and simulation in medical device submissions and notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under section 506J of the FD&C Act. Draft guidance was issued on select updates for the 506J guidance and product specific guidances for drugs. Advisory committee meetings were announced for multi-cancer detection devices, pulse oximeters and the 506J devices list. Read More