Containment Cosmetics Packaging Regulation 
FDA Law Blog
MARCH 21, 2024
As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.
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.”.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
Advarra
JULY 19, 2022
The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,
XTalks
APRIL 14, 2021
How Are Synthetic Food Dyes Regulated? The US Food and Drug Administration (FDA) defines color additives as “any substance that imparts color to a food, drug, cosmetic, or the human body. These labels must be present on the packaging of the items sold. These include FD&C Blue No. 1, FD&C Blue No.
FDA Law Blog
NOVEMBER 9, 2021
Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. By Adrienne R. Section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. Draft Guidance at 8.
FDA Law Blog
JUNE 12, 2023
By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.
Expert insights. Personalized for you.
64 
Let's personalize your content