Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day exclusivity incentive for the first generic applicant.
Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff attorneys can advertise for clients in drug and medical device cases.
Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Electronic Submission Template and Resource (eSTAR) pilot program.
Federal Register notice: FDA makes available a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.”