The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.   The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance ...

Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with the International Council’s for Harmonization’s (ICH) E2F guidance on development safety update report (DSUR), especially with regard to the cut-off date for submitting annual reports.   These comments are in response to FDA’s proposed rule issued in December 2022 outlining changes to the ...

The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.   A USP official discussed both reports, as well as...

The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical trial data for marketing authorization applications (MAAs) and post-authorization applications.   EMA issued an updated guidance on the pilot in October. (RELATED: EMA to explore reviewing raw data from clinical trials in applications , Regulatory Focus 12 July 2022)   The purpose of the pilot is to ...

Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).   Higgins outlined some of the consequences that can occur when these variables are not controlled, includin...

A proposed reorganization of the Food and Drug Administration Office of Regulatory Affairs (ORA) will “modify things significantly” for foods as well as medical products and is expected to be finalized this fall, said Janet Woodcock, the agency’s principal deputy commissioner at a 2 March webinar sponsored by the Alliance for a Stronger FDA.   Woodcock offered an update, yet few specifics, on the proposed restructuring of ORA, first floated on 31 January. Key among the...

The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current regulatory framework for pharmaceutical manufacturing in a new discussion paper.   The paper, which was jointly released by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on 1 March accompanies the agency’s release of the International Co...

[ Editor's Note: This article has been updated 3 March 2023 to clarify HDA's role in conducting the survey .]  The pharmaceutical industry and its trading partners have made “significant strides” in sharing transaction data with each other, which is a key element in medicine traceability mandated by the Drug Supply Chain Security Act (DSCSA). Yet there are still barriers to exchanging this data, according to a recent survey by the Healthcare Distribution Alliance (HDA...

Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes full effect this November, the US Food and Drug Administration (FDA) will begin inspecting firms to verify their compliance, asserted Howard Sklamberg, a partner at Arnold & Porter.   He outlined what FDA will be looking for in inspections at a 22 February webinar sponsored by the Food and D...

The European Medicines Agency (EMA) has issued a guidance in a question-and-answer format to assist sponsors in navigating the Clinical Trials Regulation (CTR) and the new clinical trials information system (CTIS) portal. Use of the CTIS became mandatory on 31 January.   The Q&A was developed by EMA’s Query Management Working Group (QMWG) to clarify some areas of ambiguity raised by stakeholders, which included the Association of Clinical Research Organizations (ACRO),...

The US Food and Drug Administration (FDA) needs to do a better job of tracking and monitoring the activities of institutional review boards (IRBs); not doing so compromises the safety of research participants enrolled in clinical trials, according to a new report from the Government Accountability Office (GAO). These findings also apply to the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP).   The 16 February report describes...

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) reported that progress has been made over the past year in advancing its quality management maturity initiative and in its quality assessment review process in its 2022 annual report.   The report also describes progress made in other areas under OPQ’s remit. The office’s previous two reports focused largely on its COVID-19 response. (RELATED:  FDA’s OPQ reports on drug quality efforts ...