FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).
Human Drugs
2 REMS Assessment MAPPs
CDER publishes two MAPPs on elements of REMS assessments.
FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).
CDER publishes two MAPPs on elements of REMS assessments.
FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).
CDER publishes two MAPPs on elements of REMS assessments.
Two attorneys who represented the Canton, MA-based Judge Rotenberg Center in its court case against FDA’s efforts to ban the use of an electroshock or aversive medical device with specified patients say the agency is not following the science and interfering in the practice of medicine.
The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gene therapy products.