The FDA and Fort Dodge

[ramanth]

A Letter of Warning from the FDA to Fort Dodge

Nice to see some things are being done.

(For those that are new to the site, Fort Dodge are the makers of ProHeart 6 Heartworm Preventative injection. It's my opinion that ProHeart6 nearly killed Kia.)

[Cinder & Smoke]

Go Get 'em, FDA!!

When you read the Warning Letter Kimmy *linked* to;
you'll probably notice the notation >>>
[ redacted ]
in MANY Places throughout the letter...

That term [ redacted ] is legal-speak for
"edited out", or "removed" or "deleated" ~
to mark places where a word or wordS were "removed" from
the original text in order to guard Trade Secrets" or
"Confidential Commercial Information".

From an FDA web site:
"Ordinarily, the following information is considered trade secret
or confidential commercial information exempt from public disclosure:

. . 1.Information about device functions, mechanics, engineering,
. . . and schematic drawings not in the proposed labeling
. . 2.Proprietary physical characteristics and performance parameters
. . . not in the proposed labeling
. . 3.Device good manufacturing practice (GMP) information
. . . (if different from what is standard in the industry).
. . 4.Manufacturing quality control information.
. . 5.Non-clinical raw data.
. . 6.Clinical raw data.
. . 7.Supplier names, customer lists, production costs, inventory,
. . . failure rates of devices, device production quality control (QC)."

Although this FDA Letter makes no mention of the
Safety Issues with the Fort Dodge "ProHeart 6" heartworm injection -
this Warning IS a form of progress -
the FDA IS *watching* Fort Dodge!

/s/ Phred

[ramanth]

I wondered what this 'redacted' was. Guess I could of asked around... *laughs*

Thanks for the lesson Phred.