
There is an important debate going on over the last 9 months regarding exactly how many different answers companies should prepare to provide in response to a DSCSA verification request. Some say two: “Red light” or “Green light”. And others say three: “Yes”, “No”, or “It’s Complicated”. This might seem like a minor question, but people on each side are surprisingly passionate about their positions. Let me explain. Continue reading DSCSA Red Light Green Light: Verification Responses
On August 21st, large portions of the United States and other places
Last week the FDA announced it will coordinate one or more pilot(s) to assist in the development of the electronic, interoperable system that will identify and trace drugs in the U.S. under the
Last week I covered the likely impact of the recent draft compliance policy currently under a 60-day public comment period (see “
Drug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy. All the headlines scream (including last week’s RxTrace essay: “
Maybe I’m just hyper sensitive to all things
FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the