FDA Law Blog
MARCH 21, 2024
As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.
XTalks
APRIL 26, 2021
The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. In terms of the certification marker, the UFA hired branding agency Modern Species to design the marker for food packaging. Even before the term was formally defined, upcycled foods had been gaining momentum.
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FDA Law Blog
DECEMBER 8, 2022
Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g.,
Camargo
NOVEMBER 15, 2021
The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above.
FDA Law Blog
AUGUST 19, 2021
The latest version of the bill again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. Regulation to establish levels of allulose, polydextrose, sugar alcohols or isolated fibers above which require a warning that the food contains levels that cause “deleterious health effects.”.
Advarra
JULY 19, 2022
Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Q: The speaker just stated that the Meeting Package is due 60 days before the meeting date.
FDA Law Blog
NOVEMBER 9, 2021
115-521 ) amended Section 745(A)(b) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include that after publication of a final guidance, pre-submissions and 510(k)s “shall be submitted solely in such electronic format as specified by the Secretary in such guidance.” Draft Guidance at 8.
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