CFDA Continues to Expand Oversea Inspection
8 March 2018
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and...
Blog: Focus On Regulation | 23 April 2013
As noted in our recent post, OIG’s recent Special Fraud Alert on Physician-Owned Entities is the strongest statement to date that investing in or doing business with a physician-owned distributor, or POD, is a significant Antikickback law risk, not only for the POD and its physician-investors but for the hospitals and ASCs that purchase from PODs and the manufacturers that sell to them. Some PODs and their promoters have reacted to the Fraud Alert by attempting to reassure investors, and the hospitals, ASCs, and manufacturers with which they do business, that the Fraud Alert is just predictable “business as usual” from OIG and if a POD was “legal” before the Fraud Alert, it is still legal. Both of these assertions seriously understate the risks to POD participants, suppliers and customers. Simply put, by identifying as “inherently suspect” features that are present in all PODs, the Fraud Alert puts to rest any myth that the POD business model can be pursued safely or lawfully. • Not Business As Usual
8 March 2018
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and...
28 February 2018
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations...
26 February 2018
On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union...
30 November 2017
The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector.