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New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely thin, nonporous metallic coatings applied by ion beam deposition, according to one of seven comments filed on the document. Read More
Can remote cognitive testing via smartphones yield reliable and valid data to evaluate people for a type of dementia? Findings of a study of 360 individuals spanning over four and a half years indicate the answer is yes. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Three FDA final guidances address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one for transmitting electronic individual case safety reports (ICSR), another for ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database and a third for expedited ICSRs from certain IND-exempt studies. Read More
A streamlined, more efficient and less burdensome pathway to medical device review is the goal of the Accreditation Scheme for Conformity Assessment (ASCA), a voluntary program the FDA is formally implementing while targeting accreditation bodies, testing labs and device manufacturers. Read More
Over the past week, the FDA published a proposed rule to ban electrical stimulation devices and issued guidance on bioavailability and bioequivalence testing samples. Draft guidance was issued on animal studies for dental bone grafting. Facility fee rates for FY 2024 for the OTC Monograph Drug User Fee program were published. Read More
A new draft guidance issued by the FDA Friday provides recommendations for using animal studies to assess the in vivo performance of dental bone grafting materials. Read More