Articles Tagged with ''FDA''

FDA Says it Can Approve Follow-On Biologics

The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More

FDA Says it Can Approve Follow-On Biologics

The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More

Postmarket Regulations Stricter For Devices Than for Drugs

Federal device postmarket authorities are "far more extensive than for prescription drugs," and the FDA and CDRH are using their authorities to maintain continued device safety, Janet Trunzo, vice president of technology and regulatory affairs at AdvaMed, said. Read More

Device Trial Sponsors Cited in Two Warning Letters

A hearing implant company sponsoring a device study failed to provide clinical investigators with information on hearing loss among participants, and the sponsor of another device clinical trial provided "misleading" assurance to participants that the investigational device had been judged safe by the FDA, according to two separate FDA warning letters posted recently to the agency's website. Read More