“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable. Background In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be […]
Month: November 2014
Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce
“HDMA’s 2014-15 Factbook updates member financial, operational performance. The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was […]
FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference
“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect. Dr. Connie Jung, Acting Associate Director for Policy and Communications for […]
It’s Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!
The holidays are coming! Don’t let your Exemptee training or Designated Representative training hang over your head going into November and December. Just get it done now, before: the kids get out of school you find yourself cooking in the kitchen shopping for the holidays Go to DREprof.com: The Designated Representative and Exemptee Training Website CA […]