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A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit. Read More
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More
The FDA has released a new Emergency Use Authorization (EUA) template to help devicemakers develop COVID-19 tests for at-home self-collection. Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More
A new biological reagent is now available to labs that will help them to develop more accurate diagnostic tests for COVID-19, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
Failure to document corrective and preventive action (CAPA) activities related to its x-ray equipment landed Deerfied Imaging a Form 483 from the FDA following an inspection of its Minnetonka, Minnesota facility. Read More
Inadequate procedures for managing corrective and preventive actions and for monitoring and controlling process parameters landed DJ Orthopedics a form 483 following an FDA inspection of its Tijuana, Mexico facility. Read More
Perahealth didn’t have any design plans for its PeraTrend and PeraServer software used in monitoring patients, and it lacked appropriate documentation for numerous quality system processes, according to a Form 483 the firm received following an FDA inspection of its Charlotte, North Carolina facility. Read More