Risk Management

The antipsychotic’s Risk Evaluation and Mitigation Strategy has never been fully implemented or enforced due to operational and technical challenges. The FDA now is re-evaluating the need for the program given changes in the health care landscape and medical training since the drug’s 1989 approval.

Indian CMOs, CDMOs and CRDMOs are expanding capacity and making leadership moves ahead of the BIOSECURE Act, anticipating demand from big pharma and budding biotechs. Scrip brings details on leading Indian firms which could be potential go-to suppliers for US companies affected by the proposed Act

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

Long-term follow-up requirements have taken a conservative approach, but could be ripe for re-examination and global harmonization, Kite Pharma executive director says, while former FDA gene/cell therapy office head Wilson Bryan wants the classwide REMS eliminated.

Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines.

The US FDA now requires mammograms include information about breast density, a significant factor that raises breast cancer risk and can hide tumors.

The US FDA updated labeling for Astellas’ drug for hot flashes after a postmarketing report of a single patient with signs and symptoms of liver injury taking the medicine. 

In this installment of HBW Insight’s “Inside Regulatory Affairs” series, Bayer Consumer Health’s global regulatory director, Jenny Holmes, describes how the job has changed in recent years to assume an enabling role for innovation.

The increasing prevalence of psychedelic truffles sold as food supplements purported to enhance mood and boost creativity is of growing concern to the European Food Safety Authority. EFSA’s Milen Georgiev tells HBW Insight how the authority is handling this emerging risk to consumers.

Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.