FDA Q&A
FDA Cosmetic Safety and Modernization Act (S2003)
Yesterday, October 2, 2018, Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act (S2003). The proposed bill, like many of its predecessors, including Personal…
FDA Microneedling Guidance
FDA microneedling guidance at long last arrived today (Sept. 14, 2018). The Draft Guidance document is available here. Previous posts on microneedling can be found here…
Medical Device User Fee Rates for Fiscal Year 2018
The US FDA announced Medical Device User Fee Rates for Fiscal Year 2018 on Monday morning (August 28, 2017). The Medical Device User Fee Rates for Fiscal Year…
Regulatory Mediator
Mediation is an increasingly used tool both by courts and parties to avoid litigation. When a dispute involves regulatory issues, such as FDA compliance questions,…
Interview on AME Food Testing Show
My Interview on Whether FSMA will Require Food Producers to Test their Products <object classid=”clsid:D27CDB6E-AE6D-11cf-96B8-444553540000″ codebase=’http://download.adobe.com/pub/shockwave/cabs/flash/swflash.cab#version=9,0,0,0′ width=’210′ height=’105′ name=”214821″ id=”214821″><param name=”movie” value=”http://www.blogtalkradio.com/btrplayer.swf?file=http%3A%2F%2Fwww.blogtalkradio.com%2Fame-foodtestingshow%2F2011%2F11%2F09%2Fwill-fsma-require-food-producers-to-test-their-products%2Fplaylist.xml&autostart=false&bufferlength=5&volume=80&corner=rounded&callback=http://www.blogtalkradio.com/flashplayercallback.aspx” /><param name=”quality” value=”high”…
FSMA Inspections
FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve both for…
Is Vape Doomed?
As state bans begin to join major city bans and the FDA announcement of a new crackdown the question many people are asking is vape…
Private: Technology and Privacy
As the number of devices that connect to the Internet increases and audio and video content offerings grow, understanding issues unique to digital media and…
See the Exemptions to the Proposed Rule for Preventative Controls for Animal Food
The charts below do not contain all of the information necessary to determine the proposed requirements for compliance in a particular circumstance. Consult the proposed…
Electronic and Radiological Devices Accession Numbers
Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product to market. Accession numbers refer to the unique FDA identifiers for…
FDA New Tobacco Deadlines
As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various…