Regulatory Oversight and Compliance

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.

These infections can be caused by certain Gram-negative microorganisms, making the infections challenging to control due to high antimicrobial resistance.

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers?

Bio/pharma companies have a lot to consider when tackling social media communications, especially within Europe.

Another eight medications already authorized in the EU were recommended for extensions of various indications.

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

Data from a Phase III study that evaluated lazertinib, in combination with amivantamab, in comparison to osimertinib as a first-line treatment resulted in the EC’s decision.

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

CNP-104 is a biodegradable nanoparticle that previously received fast track designation from FDA in January 2022, which would eventually make it eligible for accelerated approval and priority review.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.