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The agency said it “generally does not seek to interfere with the exercise of the professional judgment of healthcare providers in prescribing or using, for unapproved uses for individual patients, most legally marketed medical products.” Read More
A manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity from the accredited lab as part of a premarket submission to the FDA. Read More
The Government Accountability Office (GAO) has proposed that the FDA’s medical device, drug evaluation, and biologics evaluation centers implement formal equipment management policies after finding that their current procedures need improvement. Read More
The FDA clarified in new proposed rule how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices. Read More
TGA has authorized the supply of five products registered overseas that are similar in strength to the Australian patches, but they are also facing delays. Read More