SVP of Manufacturer, Quality, and Replenishment Operations, Cencora

Articles

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.

Preparing for Pharma’s “Y2K Moment”: What the Shift to a 12-Digit NDC Means for Manufacturers

Videos

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

Regulatory Actions for June 2026

BioPhorum launches a 20-member collaboration uniting pharma, CDMOs, and regulators to address manufacturing challenges in small molecule drug production.

BioPhorum Unites 20 Organizations to Modernize Small Molecule Production

FDA has approved Tregzi, the first regulatory T-cell therapy shown to reduce chronic GVHD and improve survival in blood cancer transplant patients.

FDA Grants First-in-Class Approval for Treg Cell Therapy in Blood Cancer Transplant Patients

The company’s thyroid eye disease treatment will be the first at-home subcutaneous disease-modifying treatment if approved.

Roche Gets Priority Review for Enspryng; Announces Sequencing Platform

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

This episode of Ask the Expert takes a look at recent regulatory actions impacting biologics manufacturers.

Regulatory Developments Impacting Biologics

The FDA again rejected Unicycive's oxylanthanum carbonate over third-party manufacturing compliance, not safety, spotlighting CMC risk in nanoparticle drug development.

Manufacturing Deficiencies Behind FDA's Oxylanthanum Carbonate Rejection

The outsourcing company is adding commercial-scale capabilities to manufacture HPAPI and ADC payload-linkers.

Lonza Increases HPAPI Production at Visp Facility

The companies have been selected to participate in the pilot program to expand domestic pharmaceutical manufacturing and strengthen the US drug supply chain.

FDA Chooses 7 Companies for PreCheck Pilot

Senior Program and Execution Leader
Independent

Documentation reliability across CDMOs, CROs, and other contractors should be engineered into quality systems before, during, and after execution, not patched together at submission or inspection time.

News