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FDA Form 483 Response Strategy – FY 2012 Inspectional Observation Summaries
FDA Form 483 Response Strategy FY 2012 Inspectional Observation Summaries FDA Form 483 response strategy – perhaps the best strategy to both prepare for a
“Can a Dietary Supplement Treat a Concussion? No”; Stretching the Reach of Dietary Supplement Claims
The US Food and Drug Administration (FDA) announced through a consumer advisory on the danger of using a dietary supplement to treat concussions or traumatic…
SNAP Trafficking Charge Letter
SNAP Trafficking Charge Letter Overview of USDA/FNS Charge Letter Response and Appeal SNAP Trafficking charge letter act as the official notification from the USDA FNS…
New FSMA Rule; FDA Proposed Rule: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
The US Food and Drug Administration (FDA) announced a new rule today under the Food Safety Modernization Act (FSMA).
Two New Studies Debunk Benefits of Multivitamins; What is the Impact on Industry?
Two studies released on Monday gained national headlines for their findings on the effectiveness of multivitamins.
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…
Trans Fat Banned Under New FDA Rule
The US Food and Drug Administration announced today it will take steps to curb the use of partially hydrogenated oils from processed foods. The Agency…
Proposed Preventative Controls and GMP Rules for Animal Food and Feed: Overview
The pet food and animal feed industry is set to make sweeping changes under the newly proposed Preventative Controls and GMP rules. The U.S. Food…
FDA/USDA Shutdown Ending, Expect Lengthy Delays
The government shutdown that shuttered the doors of the USDA and FDA has ended. The Agencies are expected to return back to normal operations on…
Shutdown Delays Medical Device Approvals (510(k)s)
As the shutdown continues the impact continues to be felt.
Government Shutdown; Update on Impact on USDA & FDA
The US federal government is shutdown. The impact will be felt by all areas of FDA and USDA regulated industry. The FDA will cease all…
FDA Annouces Significant Overhaul of Proposed Produce Safety Rule
The US Food and Drug Administration (FDA)