[Pharm-policy] RE: [Ip-health] China to Make RU-486 for U.S.

Horton, Linda R LHORTON@OC.FDA.GOV
Thu, 12 Oct 2000 19:11:44 -0400


There needs to be assurance of adherence to GMPs needed to assure that drugs
have acceptable safety, quality, potency, etc., through rigorous
inspections. 

> -----Original Message-----
> From:	James Love [SMTP:love@cptech.org]
> Sent:	Thursday, October 12, 2000 7:08 PM
> To:	Horton, Linda R
> Cc:	IP-Health list; pharm-policy
> Subject:	RE: [Ip-health] China to Make RU-486 for U.S.
> 
> On Thu, 12 Oct 2000, Horton, Linda R wrote:
> 
> > the Post article quoted from below did mention that FDA had inspected
> and
> > found acceptable whatever manufacturer it is who is making RU-486
> 
>    Yes.  And, if the Chinese can make RU-486 for American women, maybe
> the Thai, Indian, Brazilian, Korean or Chinese can make other medicines
> of  acceptable quality.
> 
>    Jamie
> 
> --------------------------
> James Love, Consumer Project on Technology, http://www.cptech.org
> love@cptech.org, v. 1.202.387.8030, f 1.202.234.5176