Dec 13, 2023 | FDA and USDA Regulatory Update, Foods
The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled Menu Labeling: Supplemental Guidance for Industry (Edition 2). To respond to frequently asked questions regarding menu labeling requirements, the draft...
Nov 29, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be...
Nov 8, 2023 | FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)...
Nov 2, 2023 | FDA and USDA Regulatory Update
FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December 2023. This draft guidance describes how the FDA will request and conduct...
Nov 1, 2023 | Foods, Issue of the Month
Review of Food Safety Needs to Export from the USA By Omar Oyarzabal PhD., Senior Consultant for Food Services Exporting foods from the USA to other countries, such as Canada and those in the EU block, has been a lucrative option for some segments of the food...
Oct 23, 2023 | Drug and Device Corner
The FDA published a new Guidance Document – Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications which articulates the agency’s evolving policy which has grown from the Pandemic era use of alternative tools in evaluating...