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TOPIC: Letter from FDA

Letter from FDA 1 year 7 months ago #25473

  • HCV2B
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I was hoping to attach a letter I received from FDA.
It says this is an unapproved new drug without a new drug application. Personal importation policy requirements not met. Cosighnee is not an approved recipient of clinical trial shipments. It also names VELASOF as the drug. Is that another name for Epclusa?
(Sofosbuvir/Velpatasvir)
I am getting worried... plus they are asking for more money (DHA). For taxes or something.
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Letter from FDA 1 year 7 months ago #25474

  • DrJames
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Hello HCV2B, Jan will have been in touch.

You're the second person we've seen get an FDA letter, which is a new thing.

So too is the notion of charging a tax. We see this randomly in the UK, but in the USA it's only just started to happen.
YMMV
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Letter from FDA 1 year 7 months ago #25570

  • Lilyfield
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This is surly a new wrinkle. I received Panovir (generic Epclusa) a year ago and had no problems. Were all the protocols followed?

I am going to see what I can find out.
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Letter from FDA 1 year 7 months ago #25573

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Hi Lily, this wrinkle did get ironed out, but yes it is getting harder to ship to the USA.

New enthusiasm for administering rules, new hires, and a flying squad doing spot inspections.

For the last 2 years we have been periodically saying the window of opportunity may get slammed shut...
YMMV
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Letter from FDA 1 year 7 months ago #25574

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Thank you Dr. James,

Yes, we were worried about this last year. Now, with a new administration, I'm being kind in my choice of words, it is even more important that people in the U.S. needing treatment, saddle up their ponies and ride!

Are ya' all listening, U.S. hepC sufferers? This works. If I can be of help, give a holler.

Thank you, again Dr. J.
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Letter from FDA 1 year 7 months ago #25584

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OK.....i got the same letter.....just pay the duty fee...... its going to take i few days longer, but ull get it...i had this whole thing happen 4 weeks ago and i am now currently on the treatment and FEELIN GOOD....dont worry man...they are just tryin to scare you....Jan will help you ....shes GREAT at this...lol.....dont worry it will be in yours hand in now time...
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