Quality Systems

Articles

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability. 

AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

The guidance provides examples of required and recommended information in the Dosage and Administration section.

FDA Publishes Guidance on Labeling Drugs and Biological Products 

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

FDA Signs Mutual Recognition Agreement with Swiss Confederation

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Pharmacovigilance Risk Assessment Committee Meeting Highlights

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Updated REMS Document for Prescription, Biological Drug Product

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future. 

Samsung Biologics Receives the Terra Carta Seal

Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.

FDA Grants Accelerated Approval for Eisai Alzheimer’s Disease Treatment

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

FDA Policy Change Heightens Debate Over Medicated Abortion 

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Regulatory Oversight and Compliance