On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Hot Topics at FDLI Enforcement, Litigation and Compliance Conference
- Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the key for distributors meeting their obligations to design and operate systems to disclose suspicious orders of controlled substances. He made particular mention of on-site visits.
- Michael Blume, Director of DOJ’s Consumer Protection Branch, spoke about the increase in cases involving manufacturing compliance as well as device defect reporting.
- Mary Malarkey, Director of CBER’s Office of Compliance and Biologics Quality, talked about recent enforcement actions involving doctors using experimental stem cell and placental tissue procedures, and efforts to stop distribution of unapproved HIV testing kits.
- Several government speakers emphasized the need for global partnering among regulatory agencies, such as collaborative inspections and sharing inspection reports. FDA has already relied on foreign agencies’ findings to prohibit imports.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017