Quality Systems

Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in July 2025.

The company’s expanded label for Avtozma (tocilizumab-anoh) now includes the treatment of cytokine release syndrome, aligning the therapy with all indications for which Actemra is approved in the US.

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.

Pharma manufacturing is headed toward smarter tools, deeper partnerships, and a renewed focus on compliance and quality at every stage of the product lifecycle.

A new nuclear magnetic resonance method reveals real-time, coordinated changes in nanoemulsion drugs, improving noninvasive analysis and regulatory evaluation.

The company’s FDA-approved first generic sertraline capsules secured a 180‑day exclusivity period, highlighting strategic generic development pathways.

The program has been transitioned to a permanent pathway that is designed to support innovative tools like artificial intelligence, wearables, and biomarkers in drug development and trials.

Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

7-OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

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.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Artificial intelligence and machine learning can help identify complex patterns.

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

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 company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

NIBRT, Firefinch, and eg technology will join the center, adding to its collective of healthcare innovators.

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.