Joanne S. Eglovitch

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.

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 @ 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 @ 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 @ 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.

The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing @essential drug delivery outputs@ (EDDOs) that deliver consistent performance.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

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 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.

The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers, called container closure systems (CCS), used to hold sterile drug or biological products administered parenterally. The guidance applies to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). @