We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
A new draft guidance issued by the FDA Friday provides recommendations for using animal studies to assess the in vivo performance of dental bone grafting materials.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
This edition of Quick Notes reviews Merck’s pulmonary arterial hypertension treatment with Winrevair, a fourth approval for AstraZeneca’s Ultomiris, Akebia approval for Vafseo tablets and another clearance for Neuronetics’ Neurostar device. Read More
The FDA and U.S. Customs and Border Protection (CBP) are partnering to promote supply chain traceability and improve the government’s visibility into imports by focusing on Global Business Identifiers (GBI), unique numbers that capture information about legal business entities and their functions within the supply chain. Read More
Comments are sought by the Scientific Committee on Health, Environmental and Emerging Risks on an update of the European Commission guidelines on the presence of phthalates in medical devices. Read More