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May 04, 2024
The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.
May 02, 2024
The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.
In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.
April 29, 2024
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.
April 25, 2024
The majority of PMCs/PMRs are proceeding according to schedule.
April 24, 2024
FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.
April 23, 2024
Regulations for mRNA products are evolving as the market for mRNA expands.
April 22, 2024
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.
April 17, 2024
Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, demonstrates QMS impact on quality maturity at INTERPHEX.