After 10 years in the making, draft legislation for modernizing how medicines and medical devices are regulated in New Zealand has been introduced in parliament for debate.

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New proposed rule calls for replacing US FDA’s current annual reporting requirements for INDs with a safety update report that is consistent the format and content of the development safety update report (DSUR) supported by the International Council of Harmonisiation.

FDA Commissioner Robert Califf says mentioning China helps increase congressional support.

Finnish government proposals to introduce pharmacy-level substitution for biosimilars have been criticized by the country’s generics and biosimilars industry association.

Many pharma firms are considering cutting their investment in clinical trials or reducing their supply to the UK market next year, a survey by industry group EMIG found.

CMS head Brooks-LaSure says agency is making progress in staffing the drug pricing control programs established by the Inflation Reduction Act. Medicare Center deputy director Cheri Rice will be its acting director under just-unveiled management structure.

Pfizer and Moderna’s ‘endemic’ COVID vaccine market scenarios anticipate much higher booster rates than have been achieved so far, but performance for 2023 may be aided by the Biden Administration campaign to increase shots this winter.

Regeneron President George Yancopoulos got in a screaming match at Milken conference, arguing paying for cures is a secondary problem that should be tackled once such products are developed. He also talked about how he believes tech companies are helping to create some of America’s health crises.

New proposed rule calls for replacing US FDA’s current annual reporting requirements for INDs with a safety update report that is consistent the format and content of the development safety update report (DSUR) supported by the International Council of Harmonisiation.

Office of New Drug Director Peter Stein says there needs to be a better way to facilitate drug repurposing to avoid wasting time and resources on theories with little scientific probability of success.

Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.

Pfizer and Moderna’s ‘endemic’ COVID vaccine market scenarios anticipate much higher booster rates than have been achieved so far, but performance for 2023 may be aided by the Biden Administration campaign to increase shots this winter.

Regeneron President George Yancopoulos got in a screaming match at Milken conference, arguing paying for cures is a secondary problem that should be tackled once such products are developed. He also talked about how he believes tech companies are helping to create some of America’s health crises.

Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.

Two documents published by the European Commission outline proposals to prepare for future health emergencies such as pandemics and the impact of antimicrobial resistance, with next-generation vaccines and novel or repurposed therapeutics high on the agenda.

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Regulators in Pakistan are consulting on draft rules that outline their plan to introduce a risk management approach to their inspection activities and the frequency at which manufacturers can expect to undergo an inspection.