Regulatory

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

The US president's most recent comments suggest tariffs on pharma are imminent and Ireland has the most to lose.

The company plans a tiered sales approach as it targets endocrinologists for hypothalamic obesity, which is more widely diagnosed than its current indication for Bardet-Biedl syndrome.

Top 30 leaders: see the list of industry influencers highlighted in the sixth edition of In Vivo's Rising Leaders series.