Tag Archives: OMB

What Should FDA Pilot?

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 Drug Supply Chain Security Act (DSCSA) in its Enhanced Drug Distribution Security (EDDS) phase starting in 2023.  Once they start work on pilot planning, they will call for proposals from stakeholders and others.  But they can’t start until they get permission from the Office of Management and Budget (OMB), and they won’t even ask OMB for permission until they collect comments on the proposed collection of information associated with establishing the pilot program.  Believe it or not, that was the Continue reading What Should FDA Pilot?

FDA Announces OMB Approval Of One DSCSA Draft Guidance

omb-logoIt’s funny.  Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document.  When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.

That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance

The Differences Between The DSCSA, FDA Rules and Guidance

???????????From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little.

Dr. Connie Jung, RPh, PhD, Acting Associate Director of Policy and Communications, in the Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research, helped put it all into perspective for me.  During one of the breaks at the recent FDA DSCSA Workshop (see “The 2014 FDA DSCSA Workshop“)  I asked Dr. Jung what the odds are Continue reading The Differences Between The DSCSA, FDA Rules and Guidance