former pharma quality insider, screaming into the abyss about FDA food, medication, medical device, vaccine & Biologic updates💊💀💉 personal: @freebirth_mami
Inescapable Nanomaterials in Drugs and Foods: the Future of the FDA
The FDA is holding a symposium discussing the additions of nanomaterials in branded & generic drugs as well as Food Contact Substances later this month: “NanoDay”
Nothing triggers people like freebirth & unassisted mamas
(Bonus points for 1st time mothers who freebirth)
It’s an incredible gift we give our children and we should be proud and shout it from the rooftops!
My son’s freebirth 1 month ago was a spiritual experience
Congrats💝
Are FCS’s tested for safety? Yes and no.
Per the FDA’s guidance on FCS’s, if exposure for a single use is <= 0.5ppb, NO safety studies are recommended or required.
On the NanoScale, is this really putting consumer safety first?
Inescapable Nanomaterials in Drugs and Foods: the Future of the FDA
The FDA is holding a symposium discussing the additions of nanomaterials in branded & generic drugs as well as Food Contact Substances later this month: “NanoDay”
Some of the topics on the agenda include “Safety Evaluation of Food Contact Substances Containing Nanomaterials”
“Food Contact Substances” (FCS) are food additives. They will be ingested and enter the body, however, are defined and regulated by FDA under 21 CFR Parts 173-178
The product is grown in Chicken Embryo Fibroblast (CEF) cells, and also contains tromethamine, traces of host-cell DNA, benzonase, and antibiotics gentamicin and ciprofloxacin.
Jynneos, the first approved vaccine for smallpox/monkey pox was given “priority review” in 2019 even though the disease was “eradicated in the US.”
My theory is that in order to keep the biologics industry profitable, FDA/CDC needs to have pandemics constantly in the pipeline.
Coincidentally, FDA held a workshop THIS WEEK discussing the need for further inclusion of pregnant women in clinical trials, which demonstrates the shift away from the ethics that exclude pregnant women in trials to protect mother and child.
This is clearly profit-driven.
These are the companies making your infant formula, face masks, test kits, IV supplies, monoclonal antibodies, vaccines, oral medications, etc.
There is nothing high-quality about biopharmaceutical Quality.
I briefly worked in postmarket quality for a company that rhymes with Babbott—here are few things I noticed:
-the company has a backlog of several thousand complaints against their testing kits, mostly for QA failures, manufacturing defects, and false positive results.
This is mostly a result of too many acquisitions, rapid growth and expansion due to needing to increase profits for shareholders quarter after quarter.
MOST companies experiencing huge sales or even a recall operate this way for years at a time until consultants are brought in.