Falls Church, VA (PRWEB) October 01, 2013
On July 12, the FDA moved to close a glaring gap in the agency’s import powers, issuing a proposed rule that grants detention authority for drugs. For the first time, FDA officials can detain drug products they believe are adulterated or misbranded. Under the proposed rule, an inspector can detain a drug for up to 20 days if he or she believes it is adulterated or misbranded. A drug importer has just 5 days to appeal the detention order after receiving it.
Plus, FDASIA allows the agency to register importers and directs it to establish Good Importer Practice (GIP) regulations.
FDAnews has invited John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy at FDA, to provide details at the Eighth Annual FDA Inspections Summit.
The past few months have seen a sharp increase in FDA’s enforcement powers: the ability to detain drug products at the border, allowing investigators to take photos in a facility without approval and new registration requirements.
Coupled with increasingly LONG and very DETAILED Form 483s and warning letters, it’s enough to make any quality or compliance professional a little nervous.
Today’s inspectors are a breed unto themselves — many have worked in industry and know where traps are hiding in your plant or its documentation. They are highly educated, clear-headed and are well trained to look into every aspect of a facilities operations.
Take a rare opportunity to pick FDA investigators’ brains — learn how they think and what they look for. Discover secrets of proving your outsourcing oversight works. Find out what’s just down the FDASIA pike. Take a sneak peek at top-notch speakers:
FDA Speakers Include:
Former FDA Speakers Include:
Other Speakers Include:
For complete pre-conference and conference schedules, click here.
WHO WILL BENEFIT
Every FDA-regulated drug, device, biologics or clinical trial company will find something of value in the Eighth Annual FDA Inspections Summit. Here’s a suggested list of potential participants from your organization:
Eighth Annual FDA Inspections Summit
New Powers, New Enforcement Posture, New Challenges
**Presented by FDAnews**
Oct. 23-25, 2013 – Bethesda, MD
Complete Summit: $1,997
EASY WAYS TO REGISTER
By phone: 888-838-5578 or 703-538-7600