Joanne S. Eglovitch

@The newly reelected president of the European Commission on Thursday proposed two legislative priorities that will affect the pharmaceutical industry, one aims to boost the competitiveness of its pharmaceutical sector and the other would tackle drug shortages by reducing dependence on medical treatments and ingredients sourced from outside the region.

Generic drugmaker Sun Pharmaceuticals was reprimanded by the US Food and Drug Administration (FDA) for several violations of good manufacturing practices (GMPs) at one of its facilities in India. @

The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing @essential drug delivery outputs@ (EDDOs) that deliver consistent performance. @

San Diego @ The EU@s updated clinical trials portal, along with new transparency rules that require sponsors to list information on their trials in the Clinical Trial Information System (CTIS), went into effect on 18 June. Under the new rules, information on 4,000 clinical trials will now be publicly available, announced Ana Zanoletty Perez, head of the clinical trials transformation workstream for the European Medicines Agency (EMA), at the DIA 2024 Global Annual Meeting.

San Diego @ The EU@s updated clinical trials portal, along with new transparency rules that require sponsors to list information on their trials in the Clinical Trial Information System (CTIS), went into effect on 18 June. Under the new rules, information on 4,000 clinical trials will now be publicly available, announced Ana Zanoletty Perez, head of the clinical trials transformation workstream for the European Medicines Agency (EMA), at the DIA 2024 Global Annual Meeting.

San Diego @ Cell and gene therapy (CGT) manufacturers should take advantage of the numerous pathways available and meet with the US Food and Drug Administration early to iron out any questions they have during product development, Najat Bouchkouj advised at the DIA Global Annual Meeting. @

San Diego @ Pharmaceutical industry officials generally gave high marks to the US Food and Drug Administration@s (FDA) Model-Informed Drug Development Paired Meeting Program (MIDD) and lower marks to the Advancing Real-World Evidence (RWE) pilot during a panel at the DIA 2024 Global Annual Meeting on 18 June. @

San Diego @ The US Food and Drug Administration@s (FDA) top biologics official said the proposed Promising Pathways Act would lower the bar for approving treatments for rare diseases and that the existing accelerated approval pathway suffices in bringing treatments to the market that fulfill unmet medical needs.

San Diego @ Best practices for artificial intelligence in the pharmaceutical industry don@t need to be built from scratch, and instead could be based on guidelines developed by government entities and standards organizations, said Rose Purcell, director of global regulatory policy and innovation at Takada, at the DIA 2024 Global Annual Meeting.

The US Food and Drug Administration (FDA) on Wednesday announced it will grant small dispensers a two-year extension for complying with the enhanced tracking requirements for drugs under the Drug Supply Chain Security Act (DSCSA). These systems were supposed to go live on 27 November 2024 after a one-year stabilization period and will now go into effect on 27 November 2026 for applicable entities. @

The US Food and Drug Administration@s (FDA) recently launched CDER Center for Clinical Trial Innovation (C3TI) is meant to inform sponsors about innovative approaches to clinical trials, said Kevin Bugin, deputy director of operations in the Office of New Drugs (OND) and the leader of the C3TI program. @

The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to support drug development. The guidance will be informed by the agency@s experience in reviewing submissions containing AI/ML elements, as well as feedback it received on two discussion papers on the topic released last year, said Tala Fakhouri, associate director for policy analysis in the Office of Medical Policy (OMP) at FDA@s Center for Drug E…

WASHINGTON @ The US Food and Drug Administration (FDA) does not intend to further delay enforcement of requirements for manufacturers@ track and trace verification systems under the Drug Supply Chain Security Act (DSCSA) and expects those systems to be up and running this November, asserted Patrizia Cavazzoni, director of the agency@s Center for Drug Evaluation and Research (CDER). @

A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR) poses a challenge for sponsors conducting combined studies of different types of products subject to these regulations. Each regulation has different rules and criteria that apply to clinical research of medical products in the EU, according to a recent study released under the COMBINE initiative.

Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, FDA Commissioner Robert Califf testified on the agency@s response to the ongoing outbreak of highly pathogenic avian influenza in dairy cattle, among other issues facing the agency, at a Senate Appropriations subcommittee hearing on Wednesday.

Peter Marks, director of the US Food and Drug Administration@s (FDA) Center for Biologics Evaluation and Research (CBER), said his center is doing a @pretty good job@ of filling positions under the current Prescription Drug User Fee Act (PDUFA VII) agreement at a meeting sponsored by the Friends for Cancer Research (FOCR) and Parker Institute for Cancer Immunotherapy (PICI) in Washington, DC on Monday. @

The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency@s Center for Drug Evaluation and Research (CDER). @

The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling approach to support different generic drug development programs, potentially from different sponsors, in lieu of conducting clinical studies, according to officials who spoke at a 3 May workshop. @

The US Food and Drug Administration@s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued two draft guidances related to cell and gene therapy testing: one addresses safety testing products derived of human allogeneic cells expanded for use in cell-based products and the other addresses testing animal- and human-derived materials in the manufacturing of cell and gene therapy and tissue engineered medical products (TEMP). @

The US Food and Drug Administration@s (FDA) has issued a trio of draft guidance documents that aim to promote greater participation and diversity in oncology clinical trials by expanding eligibility criteria. The documents address three areas: laboratory values, washout periods and concomitant medicines, and patient@s performance status.