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The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
The FDA is holding fast to the requirement that any facility administering these treatments needs to have on-site a minimum of two doses of tocilizumab. Read More
Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Read More
Most top-selling medications are protected by dozens of patents covering various ingredients. manufacturing processes, and intellectual property. Read More
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