Regulatory/GMP Compliance

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

Asking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.

An ordered process describing calculations activities for compounded dosage forms is described.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

The majority of PMCs/PMRs are proceeding according to schedule.

Regulations for mRNA products are evolving as the market for mRNA expands.

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

FDA has published final guidance documents regarding validation and development of analytical procedures.