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Regulatory

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

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.

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

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.

Loper Bright Could Trip FDA On Self-Affirmed GRAS

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.

Preamble ‘Poison Pill’ Could Haunt ACNU Switch Rule – House Energy And Commerce Members

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.”

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

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

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

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.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

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.

Will Irish Eyes Still Be Smiling When Trump Tariffs Hits Pharma?

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

Rhythm Anticipates Smooth Sailing For Setmelanotide After Phase III Success

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.

In Vivo’s 2025 Rising Leaders At A Glance

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