Regulatory Oversight and Compliance

FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.

Science, circularity, regulation, and technology are reshaping how the industry develops packaging for medicines.

Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.

Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.

The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.

Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.

At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.

Agentic AI changes the question from what a model can produce to what a system is allowed to decide.

Pharma's AI ROI gap isn't strategy or tech; it's the missing workforce qualification step every other regulated capability requires.

A phased playbook for moving life sciences data warehouses to a compliant, AI-ready cloud lakehouse, balancing GxP rigor with faster insights.

Checking in at 2026's midyear mark, LGM Pharma's Mike Stenberg revisits his 2025 predictions on inspections, onshoring, GLP-1 delivery, and AI adoption.

The future of compliant AI is not better content generation. It is better control over what happens next.

Epista's Henrik Johanning revisits his 2026 predictions on QRM, Annex 1, AI governance, and regulatory convergence: What's tracking, what isn't.

A warning letter, a hard look at why “a human reviews it” doesn’t settle anything, and one company’s argument that accuracy was never the real problem.

FDA’s CNPV pilot aims to speed drug reviews but raises questions about safety trade-offs, resource strain, and unclear incentives for sponsors.

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.