Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them to report adverse events directly to the FDA’s MedWatch reporting system. Read More

The ongoing effort by the FTC to remove what it labels improper and inaccurate — or “junk” — listings of drug patents in the FDA’s Orange Book continues, with all cited drugmakers refusing to delist the 300 patents called out by the commission on April 30. Read More

In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the deadly side effects of a painkiller. Also, when is an orphan device an orphan? Read More

The FDA issued a complete response letter (CRL) for foscarbidopa/foslevodopa (ABBV-951) based on observations from an inspection at one of AbbVie’s third-party manufacturing facilities, the company announced yesterday. Read More

In a reversal of the previous court’s decision, the US Court of Appeals for the Federal Circuit gave Amarin a win in its fight over Hikma’s generic version of Amarin’s cardiovascular drug Vascepa (icosapent ethyl). Read More

The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining staff, according to a new CDER report. Read More

Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Read More

The FDA is seeking comments on both its information technology (IT) and its customer experience strategies to guide its work and its allocation of budget and resources in the coming year. Read More