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Latest Blog posts
The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?
While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the…
Summary of FDA Advisory Committee on COVID-19 Vaccines (Oct 22)
On Oct. 22nd, the Vaccines and Related Biological Products Advisory Committee from FDA held a nine-hour virtual meeting (Advisory Committee Meeting) to…
What are the Need-to-Know incentives associated with an Orphan Drug Designation (ODD)?
With a low prevalence, rare diseases affect six to eight percent of the population worldwide and therefore represent a global…
Tips to Select the Right Notified Body
In Europe, the review and approval of medicinal products involve Medicinal Competent Authorities from A to Z, the review and…
New FDA Guidance on Multiple Function Device Products & Its Impact on Software as A…
While the original Apple Watch was a genuine consumer product with fitness tracking and health-oriented capabilities, the adjunct of the…
New Guidance on Clinical Evaluation of Medical Device Software
The Medical Device Coordination Group (MDCG) recently published a new guidance entitled “Guidance on Clinical Evaluation (MDR) / Performance Evaluation…
Advice on Non-clinical and Clinical Development for ATMPs from an Ex-CAT member
Gene Therapies and Cell-based products, referred to as Regenerative Medicine Advanced Therapy (RMAT) in the USA and as Advanced Therapy Medicinal…
Expectations from Regulatory Agencies on Nitrosamine Impurities
On Friday, 27th March 2020, the European medicines regulatory network extended the deadline to complete an initial risk evaluation for…