Cosmetics Manufacturing Packaging Regulation 
Pharma in Brief
NOVEMBER 20, 2023
The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product.
FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.
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FDA Law Blog
NOVEMBER 16, 2021
Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.
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). FDA Publishes ICH Guidelines on Continuous Manufacturing. Batch steps include filter drying, milling, and packaging.
XTalks
SEPTEMBER 17, 2020
The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging.
Advarra
SEPTEMBER 8, 2022
One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.
pharmaphorum
OCTOBER 27, 2022
Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Companies should monitor, moderate and, where appropriate, delete inappropriate comments in a timely manner.
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