Fwd: FDA to Allow Faster Approval for Generic Drugs; Big Drugs disappointed

[Guest guest]

" luckypig "

Tue, 14 Oct 2003 21:22:55 -0400

FDA to Allow Faster Approval for Generic Drugs;

Big Drugs " disappointed "

 

 

>

> FDA to Allow Faster Approval for Generic Drugs -WSJ

> Tue Oct 14, 4:03 AM ET

>

> NEW YORK (Reuters) - The Food and Drug Administration

>

<http://us.rd./DailyNews/manual/*http://search./search?p=%

22Food+and+Drug+Administration%22 & h=c>web

> sites) is likely to signal that it will allow some generic drug makers to

> use a faster approval process, disappointing large drug companies that

have

> protested the alternative route, the Wall Street Journal said on Tuesday.

>

>

> The alternative method of drug approval, called 505(b)(2), could cut years

> off some generic drugs' entrance to the market and could be used to

approve

> the first generic biotechnology drugs, said the Journal.

>

> Three opponents to the drug approval process have filed petitions with the

> FDA to limit the back-door process, but the agency will find it difficult

> to rescind the system that is used for other kinds of pharmaceutical

> products, the Journal reported, citing people familiar with the matter.

The

> FDA is likely to suggest the faster approach will be allowed for some

> generic drug companies as early as Tuesday, the paper said.

>

> The 505(b)(2) process for generic drugs does not require the original

proof

> of safety and effectiveness mandatory for approving new brand-name drugs,

> nor does it require the same reams of data needed for approving of

> non-branded generics, said the Journal.

>

>

>

http://story.news./news?tmpl=story & u=/nm/20031014/hl_nm/health_fda_

report_dc_1

>

 

 

 

 

 

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