Update on 76471 RE: 76418 FDA Freedom of Information Act Appeal: FOIA 2024-5142
The information and concerns you shared in your messages were forwarded to the appropriate staff within FDA’s Center for Biologics Evaluation and Research (CBER).
More news from FDA
Following on from yesterday’s post below:
I received an email this morning as so:
“Dear Hedley:
Thank you for your follow-up message to the U.S. Food and Drug Administration (FDA). Your email has been forwarded to FDA’s Center for Biologics Evaluation and Research (CBER) for response. One of seven centers within the FDA, CBER is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic products, tissue, and cell and gene therapy products.
The information and concerns you shared in your messages were forwarded to the appropriate staff within FDA’s Center for Biologics Evaluation and Research (CBER). Should there be the need for follow up on the information you provided, someone may contact you to obtain further information.
Please know that once your concerns are submitted, we are not able to comment on the progress of any investigation that may take place as a result.
I hope this is helpful.
Sincerely,
Matt Lardieri
Health Communications Specialist
Center for Biologics Evaluation and Research
Office of Communications, Outreach and Development
U.S. Food and Drug Administration
Tel: 800-835-4709
OCOD@fda.hhs.gov”
What odds would you give on a response?
For those subscribers who like a flutter, what odds would you give on a response?
On the one hand, it is good to get the previous responses from FDA CBER. On the other hand, they can happily ignore what I have sent and no one would know.
What is your money on?
I have just responded as follows:
Dear Matt,
Your email is very much appreciated. Thank you for taking the time to respond.
If I may also add, for whoever it may concern, that the issues I have raised in the document FDA has, indicate serious, life threatening non-compliances with cGMP and USP <1079> at the following facilities in the COMRINATY registered supply chain:
• Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, 1 Burtt road, Andover, MA 01810 (COMRINATY, BLA 125742, drug substance (DS) manufacture).
• Pfizer Manufacturing, Rijksweg 12, Puurs 2870, Belgium NV. (COMRINATY, BLA 125742, drug product (DP) manufacture.
• Rentschler Biopharma, Erwin-Rentschler-Str.21, 88471, Laupheim, Germany (COMRINATY, BLA 125742, (drug substance (DS) manufacture).
If I receive no response to my comments, and it subsequently transpires that my concerns were valid, and patient safety was jeopardized by lack of FDA action, then I have done my level best to sound a warning bell calling for regulatory action.
Sincerely,
Hedley
"The resources required to answer your questions are not available due to budget and time and staffing constraints."