Human Drugs
FDA Reminds Drug Makers About Status Report Due 2/14
FDA reminds all ANDA and NDA holders about a one-time report that is due 2/14 on the market status for all approved drug products.
Medical Devices
United Health Products PMA Filed for HemoStyp
United Health Products files a PMA for HemoStyp for use in internal procedures.
Human Drugs
CDER/CBER Plan on Data Standards
CDER and CBER release their Data Standards Strategy FY2018-FY2022 that commits the centers to continue the development, implementation, and maintenanc...
Human Drugs
FDA Approves Amag Pharma Expanded Label for Feraheme
FDA approves an Amag Pharmaceuticals supplemental NDA to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic ki...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/2/2018.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Regulatory Review Period Determined for Duavee
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Duavee (conjugated estrogens/bazedoxifene ...
Federal Register
Regulatory Review Period Set for Edwards Sapien Valve
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Edwards Lifesciences Sapien XT Transcathet...
Human Drugs
Allergan sNDA for Avycaz Approved by FDA
FDA approves an Allergan supplemental NDA to expand the approved use of Avycaz (ceftazidime and avibactam) to include treating hospital-acquired bacte...
Medical Devices
Firm Recalls 60,000 Lots of Contaminated Eye Wash
Kareway Products recalls 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, four fluid ounces due to the potential for microbial conta...
