Quality Systems

The FDA approved the first orexin receptor agonist for narcolepsy type 1, which validates a new mechanism-driven approach shaping CNS drug development and regulatory pathways.

PharmTech spoke with Dr. Hui-Yin (Harry) Li, president and CEO of Wilmington PharmaTech, about steps that should be taken to build a productive relationship between sponsor and contract organizations.

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control.

FDA revises draft guidance for 17 generic peptide products, including semaglutide and tirzepatide, updating testing standards ahead of a September comment deadline.

Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines.

AI is reshaping discovery, manufacturing, and supply chain routing. Manufacturers are investing in capacity and resilience.

FDA advisers vote to allow pharmacy compounding of unapproved peptides BPC-157, KPV, TB-500, MOTs-C despite thin safety data and industry ties.

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explain a company’s regulatory affairs department is subject to inspections by regulators and should, therefore, be prepared.

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market.

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

FDA finalizes bioequivalence guidance for topical corticosteroids and new meeting rules for OTC monograph drug sponsors, replacing a 1995 standard.

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

FDA proposes a hub-and-spoke manufacturing registration rule and approves three drugs for multiple myeloma, IgA nephropathy, and bladder cancer.

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments.

FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

To drive long-term success, CROs need to strengthen their focus on efficiency, automation, data integrity, and compliance to generate higher ROI for clients.

FDA approves a new IgA nephropathy therapy that targets two immune cytokines at once, offering a weekly, self-administered treatment option.

EMA starts phased review of daraxonrasib for metastatic pancreatic cancer, testing a faster assessment model under reformed EU pharma rules.

PharmTech spoke with Gabriela Grasa Mannino, Senior Director, Advanced Supply Chain Solutions, US Pharmacopeia about the current state of the drug supply chain and what actions USP is taking to make supply more secure.

An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.

FDA's 12-digit NDC rule demands industry-wide barcode, labeling, and data system overhauls, manufacturers must act now to avoid pharma's Y2K moment.

June saw regulators look back at their achievements, take stock of drug shortages, and advance treatments for rare diseases.